MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.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.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Dhr review: as no lot number was provided, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: no trend considering the following event is identified: medical : revision due to dislocation event description: it was reported that patient underwent the primary surgery on november 30, 2018 and received ml taper stem, continuum cup/poly liner and biolox delta head.Subsequently, the patient underwent revision surgery on (b)(6) 2019 due to the fact that the cup was not in correct alignment.Stem was okay and kept in the patient.It has been also stated that the biolox delta head was black coloured and they suspected the source of this black colour on the head.Review of received data: photos of the explanted ceramic head were received.Devices analysis: visual examination: the biolox delta head was received for the investigation.Lot number of the head is not given, however, the serial number of the head is visible and reads as follows: 16@3265431.The articulation surface of the ceramic head is observed to be excessively covered with metallic transfer supposedly coming from the metallic cup.On the taper zone of the head metallic transfer in the form of circumferential concentric lines is seen which would indicate a symmetrical positioning of the head on the stem.Review of product documentation: this device is intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Surgical technique of ceramic heads are not existing, however, correct positioning of the implant could be found in the st for the stem.- no lot of the biolox delta head was reported.However, detailed search on the serial number of the head identified 4 possible lots as follows: 2864748, 2864749, 2864750, 2864751.Conclusion summary: review of the device history records for the possible lots of the product did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).Neither x-rays, nor operative notes, office visit notes were received.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), soft tissue laxity and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.However, as the surgeon stated revision surgery was done due to malpositioned cup during the primary surgery in another hospital it is highly possible that the ceramic head dislocated from the cup due to the wrong positioning of the cup.After the dislocation probably the head came in contact with the metallic cup and due to the contact for some time it got excessive metal transfer on its articulation surface.Based on the returned product and the given information the complaint could be confirmed, but no exact root cause could 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 DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8454835
• Report Number: 0009613350-2019-00166
• Device Sequence Number: 345155
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: 00889024430334
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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 Model Number: N/A
• Device Catalogue Number: 00-8775-032-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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