MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS AXLE; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Pain (1994); Impaired Healing (2378)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01217, 0001825034-2021-01218, 0001825034-2021-01219, 0001825034-2021-01220, 0001825034-2021-01221, 0001825034-2021-01222, 0001825034-2021-01223, 0001825034-2021-01225, 0001825034-2021-01226.Concomitant medical products: oss reinforced yoke, item# 150493, lot# 211420.Oss tibial poly bearing 20mm, item# 150414, lot# 237060.Oss poly lock pin, item# 150478, lot# 348850.Oss non-mod tib plate short 67, item# 150417, lot# 203610.Oss 7cm segmental femoral rt, item# 150354, lot# 756200.Oss poly tibial bushing, item# 150476, lot# 460720.Oss poly femoral bushings, item# 150477, lot# 370100.Oss reinforced yoke, item# 150493, lot# 658130.Oss tibial poly bearing 22mm, item# 150415, lot# 382120.Oss 3cm ellip diaphyseal seg, item# 150461, lot# 150610.Oss cemented im stem 15mmx90mm, item# 150363, lot# 810360.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately two months¿ post implantation due to wound healing problems that disengaged his hinged femur from his right tibial component.This was a result of having had a distal femoral replacement with absence of collateral ligaments causing the femur to disengage from the tibia when the knee became flexed.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSS AXLE
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11716397
• Report Number: 0001825034-2021-01224
• Device Sequence Number: 4244865
• Product Code: JDI
• UDI-Device Identifier: 00880304002487
• UDI-Public: (01)00880304002487(17)281026(10)543370
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 150480
• Device Lot Number: 543370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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