MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, M, 32/0, TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item number: 00875801232, item name: constrained liner with constraining ring 32 mm i.D.Size kk for use with 56 mm o.D.Size kk shell, lot #: 63388511.The manufacturer did not receive x-rays, or other source documents for review.He 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.(b)(4).
Event or Problem Description
A patient is pursuing a product liability claim because underwent revision surgery.Unknown at the moment the reason.
Event or Problem Description
Please refer to report 0009613350 - 2018 - 01128.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend analysis could be performed as no specific event information is available.Event description: it was reported that the patient underwent the fourth revision on (b)(6) 2016 due to unknown reason.The biolox option head (ref: (b)(4).Lot: 2851914) and the longevity constrained liner (ref: (b)(4).Lot: 63388511) 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).(winterthur) and (b)(4).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).Review of received data: based on the invoice of the surgery, the liner and the head were revised.No medical data such as x-rays, surgical notes or any other case-relevant documents receive device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was not approved by zimmer biomet.As per u.S.Regulations, ceramic head are not to be used with constrained liners.Conclusion: it was reported that the patient underwent the fourth revision due to unknown reason approximately 5 days after the previous revision due to infection.The quality records shows that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The detail information of the event is not available; the reason of revision is unknown.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received.Therefore, the condition of the component is unknown.Further, the patient's adherence to rehabilitation protocol is also unknown.However, since the combination of the head and liner is not allowed by zimmer biomet, the root cause of the event is considered as off-label use.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, 32/0, 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: 8046013
• Report Number: 0009613350-2018-01128
• Device Sequence Number: 1473389
• Product Code: LZO
• UDI-Device Identifier: 00889024430488
• UDI-Public: 00889024430488
• Combination Product (Y/N): N
• 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): 04/15/2019

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: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-032-02
• Device Lot Number: 2851914
• 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: 04/05/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 04/15/2019
• 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