MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, XL, 36/+7, 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	No Code Available (3191)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells catalog#: 00630505036; lot#: 64095405.Therapy date: unknown.The manufacturer received other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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
Patient was implanted on the left side and underwent revision surgery during which patient was implanted with a biolox head.Subsequently, the patient experienced implant dislocation and required medical intervention to re-establish component positioning.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
Event description: it was reported that the patient underwent an initial hip arthroplasty on (b)(6) 2010 and underwent revision on (b)(6) 2018.During revision surgery, the patient was implanted with a biolox head.Subsequently, the patient experienced implant dislocation (b)(6) 2018 and required medical intervention to re-establish component positioning.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.No medical documents have been received.Legal documents have been received, descibing the patient's medical history and the legal claim.No findings relevant to the dislocation.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient underwent an initial hip arthroplasty on (b)(6) 2010 and underwent revision on (b)(6) 2018.During revision surgery, the patient was implanted with a biolox head.Subsequently, the patient experienced implant dislocation (b)(6) 2018 and required medical intervention to re-establish component positioning.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).As no x-rays have been received, the correct implant positioning cannot be analyzed.The reasons for hip dislocation are multifactorial, with contributing factors from the patient, the implant, and the surgical procedure.Possible root causes include wrong head offset choice, inadequate assembling procedure, high patient acitivity, inadequate information during patients counseling by surgeon leading to premature failure caused by patient behaviour, patient disregarding the limits of the device or joint laxity.In conclusion, as the cause may be multifactorial an exact root cause could not be identified.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, XL, 36/+7, TAPER 12/14
• Common Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10654585
• Report Number: 0009613350-2020-00481
• Device Sequence Number: 14239249
• Product Code: LZO
• UDI-Device Identifier: 00889024430549
• UDI-Public: 00889024430549
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-04
• Device Lot Number: 2813813
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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