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 Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device: liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell; item#00630505636; lot# unknown.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) manufacturing (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.The manufacturer did not receive x-rays or any other source document for review.As no lot number was provided, the device history records could not be reviewed.The manufacturer did not receive the device for investigation.The investigation of the case and the process of gaining necessary information is ongoing.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 biomets reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision due to instability.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that the patient underwent right hip surgery on (b)(6)2019 and was revised due to instability on (b)(4)2020.Harm: s3 - instability, moderate hazardous situation: unknown.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Our legal department is well trained and passes all information concerning the case to our complaint handling department.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed because not all device identifications are known.5.Conclusion: it was reported that the patient underwent right hip surgery on (b)(6)2019 and was revised due to instability on (b)(6)2020.Neither x-rays, operative notes, office visit notes, nor device or photos of the device were received; therefore the condition of the component is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity, and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.The investigation did identify a non-conformance or a complaint out of box (coob).Based on the investigation the reported event cannot be confirmed.The need for corrective measures is not indicated and zimmer switzerland manufacturing 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: 12414000
• Report Number: 0009613350-2021-00456
• Device Sequence Number: 3577253
• Product Code: LZO
• UDI-Device Identifier: 00889024430549
• UDI-Public: 00889024430549
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-04
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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; Required Intervention