MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED PRECOAT TIBIAL COMPONENT SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Arthritis (1723); Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: nexgen tivanium lps-flex option femoral component size e left catalog #: 00596801551 lot #: 64017665, nexgen standard all poly patella 32mm catalog #: 00597206632 lot #: 64178939, nexgen lps-flex prolong articular surface ef 12mm catalog #: 00596203212 lot #: 63658236.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-00847, 0001822565-2023-00849, 0001822565-2023-00851.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision approximately four (4) years post-operatively due to pain, instability, femoral loosening, recurrent patellar dislocations and patellar fragmentation.Competitor devices were used to complete the procedure.Revision operative records indicate that the knee joint was grossly unstable to varus-valgus stress and anterior-posterior stress.The femoral component was loose when tapped and the patellar component had uncovered eburnated bone.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned implants showed signs consistent with being implanted (scratched/nicked).The femoral and tibial components had foreign material on the distal surfaces and the posts of the patella and articular surface implants appeared to have been cut off and were not returned.Medical records reviewed confirmed the event reported.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information provided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN STEMMED PRECOAT TIBIAL COMPONENT SIZE 3
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16652327
• Report Number: 0002648920-2023-00058
• Device Sequence Number: 12274046
• Product Code: JWH
• UDI-Device Identifier: 00889024217577
• UDI-Public: (01)00889024217577(17)280930(10)64158604
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 00598003701
• Device Lot Number: 64158604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 93 KG