MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, M, 36/0, TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item number: 00625006525, item name: bone screw self-tapping 6.5 mm dia.25 mm length, lot # 63176656.Associated item number: 00875101236, item name: neutral liner 36 mm i.D.Size kk, for use with 56 mm o.D.Size kk shell, lot # 62874474; item number: 00625006535, item name: bone screw self-tapping 6.5 mm dia.35 mm length, lot # 62959152; item number: 00625006540, item name: bone screw self-tapping 6.5 mm dia.40 mm length, lot # 63171804; item number: 00875705602, item name: shell with multi holes porous 56 mm o.D.Size kk for use with kk liners, lot # 62466930; item number: 00630505036, item name: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, lot # 63117945; item number: 00620105400, item name: replacement locking ring for use with 54 mm shell, lot # 63220996.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that patient underwent revision surgery due to dislocation.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: if follow-up, what type.Correction: date of report, pma/510k.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: dislocation event description: it was reported that the patient underwent the second revision on (b)(6) 2016 due to recurrent dislocation.The biolox option head (ref: (b)(4), lot: 2826143) and the continuum longevity neutral liner (ref: (b)(4), lot: 62874474) were revised.This is a split case with warsaw (b)(4).Primary right tha was done on (b)(6) 2008.First revision due to wear, metallosis and pain is done on (b)(6) 2016, captured under (b)(4).Second revision due to dislocation done on (b)(6) 2016 is captured under (b)(4) (warsaw) and (b)(4) (this complaint).Third revision due to infection done on (b)(6) 2016 is captured under (b)(4) (winterthur) and (b)(4) (warsaw).Fourth revision due to unknown reasons done on (b)(6) 2016 is captured under (b)(4)(winterthur) and (b)(4) (warsaw).Review of received data: the attorney letter mentioned that, due to the adverse local tissue response and metallosis, secondary to trunnionosis, the patient suffered recurrent dislocations after her first revision surgery, which required a second revision surgery and placement of a constrained liner.The invoice of the surgery shows that both liner and head were exchanged.No medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Root cause analysis: root cause determination using sap rmw: failure of connection between stem and ball head, dislocation, subluxation, abrasive wear due to inadequate taper connection design leads to dissociation of the ceramic head (taper connection not able to resist the impaction force) not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, dislocation, subluxation, abrasive wear due to inadequate head/adapter design leads to impingement; limited range of motion not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, dislocation, dissociation, implant breakage due to insufficient connection strength between head/adapter construct and stem due to insufficient material properties and/or design not possible, as according to material compatibility specification sap 142889 the material has been tested.Further, a systematic issue with material properties and design would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, dislocation, dissociation, implant breakage due to insufficient connection strength between head and adapter due to insufficient material properties and/or design => not possible, as according to material compatibility specification sap 142889 the material has been tested.Further, a systematic issue with material properties and design would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, postoperative tissue reaction, metalosis, dislocation, dissociation, aseptic loosening of stem, osteolysis due to insufficient connection strength / micromotion leading to wear in taper connection between stem and head/adapter construct possible, as no sufficient information and the condition of the explanted device is unknown, the cause could not be excluded.Postoperative tissue reaction, metalosis, dislocation, aseptic loosening of stem, osteolysis due to pe, ceramic or metal particle release from articulation (head and inlay) or taper (head/adapter construct and stem) connection due to wear possible, as no sufficient information to exclude the cause.Postoperative tissue reaction, dislocation, aseptic loosening of stem, increased wear, osteolysis due to increased friction for ceramic-on-poly or ceramic-on-ceramic bearing leading to loosening of components or increased wear possible, as the condition of the explanted device is unknown and no relevant document received.Failure of connection between stem and ball head, dislocation, subluxation, dissociation, abrasive wear, limited rom, impingement due to inadequate head and/or adapter design leads to impingement (component to bone) with stem not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, dislocation, subluxation, dissociation,abrasive wear due to adapter to head impingement (component to component) possible, as no sufficient information available.Implant breakage, abrasive wear, dissociation, nerve injuries, vascular injuries due to design specification not met (e.G.Head/adapter construct does not provide feedback during assembly onto stem taper) possible, as the device was not returned for investigation.However, it is unlikely as a systematic issue would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head/adapter, dislocation, subluxation, abrasive wear due to impingement (component to bone, component to component, component to soft tissue) due to malposition of components (stem, head, cup) possible, as no x-ray image received, the positioning of the components is unknown.Dislocation, subluxation, leg length discrepancy, aseptic loosening of components due to selection of wrong components (e.G.Wrong size of head diameter and/or offset and/or wrong head/adapter taper) possible, as no sufficient information available to evaluate the component selection.However, the size of head and liner is compatible.Failure of connection between stem and ball head/adapter, implant breakage, corrosion, metalosis, dislocation, subluxation, abrasive wear due to head is implanted on a damaged stem taper; usage of a wet and/or unclean stem and/or head/adapter taper (particles between stem taper and ball head/adapter taper) possible, as no specific information available.Failure of connection between stem and ball head/adapter, abrasive wear, fretting corrosion, dislocation, dissociation, implant fracture, soft tissue impingement due to inappropriate assembling of head/adapter construct with stem (e.G.Insufficient impaction force and/ or off axis impaction, torque on head) possible, as no specific information available.Failure of connection between stem and ball head/adapter or head and adapter, abrasive wear, fretting corrosion, dislocation, dissociation, implant fracture, soft tissue impingement due to inappropriate assembling of head with adapter possible, as no specific information available.Dislocation, subluxation, abrasive wear, leg length discrepancy, impingement, limited range of motion due to soft tissue laxity as no specific information regarding soft tissue tension available.Fracture of head, dislocation, subluxation due to biolox option head implanted without the use of biolox option adapter possible, as niether the device nor a photo of the explanted device was received, the use of adapter could not be confirmed.Failure of connection between stem and ball head/adapter or adapter and head, abrasive wear, fretting corrosion, dislocation, dissociation due to explanted ceramic head and/or adapter is reused with the same or new femoral stem not possible, the purchase order sheet indicated that the head is not reused.Failure of connection between stem and ball head/adapter, abrasive wear, dislocation, subluxation, fracture of head, leg length discrepancy due to off label use; wrong combination of components used; combination with competitor products not possible, the compatibility was confirmed.Implant breakage, dislocation due to inappropriate advice by surgeon to inform patient on postoperative activities and limits.Possible, as no specific information available.Conclusion: it was reported that the patient underwent the second revision due to recurrent dislocation approximately 4 months after the first revision due to metallosis.The quality records shows that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received; the condition of the component is unknown.The complaint could not be confirmed.Further, the adherence of patient to rehabilitation protocol is unknown.The contributors to the event include the position of the thr, the selected size/neck length of the component, impingement, assembly of the head to taper and soft tissue tension, etc.However, due to the lack of information, it is impossible to performed a meaningful analysis of the reported event.Therefore an specific root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX OPTION, HEAD, M, 36/0, TAPER 12/14
• Common Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8037287
• Report Number: 0009613350-2018-01127
• Device Sequence Number: 1187827
• Product Code: LZO
• UDI-Device Identifier: 00889024430525
• UDI-Public: 00889024430525
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-02
• Device Lot Number: 2826143
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention