MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZSS POLYETHYLENE INSERT XT SIZE C USE WITH DISTAL FEMORAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total knee arthroplasty.Approximately 3 years postop, the patient was revised due to the segmental hinge post and segmental poly insert breaking.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00585003012 - articular surface with segmental hinge post size c 12 mm height - 64924221.00585004302 - distal femoral xt component size c right use with polyethylene insert xt size c use with xt only for cemented use only in the u.S.A.- 64980485.00585205012 - fluted stem extension straight precoat for cemented use only 12 mm diameter 130 mm length - 64834046.00585204030 - stem collar 30 mm o.D.For use with 16 mm or smaller diameter segmental stems - 64887257.00598802011 - 11mm diameter 100mm length offset stem extension combined length 145mm - 63981062.00588000300 - size 3 precoat cemented tibial component - 64591106.00598800326 - tibial block and screws precoat size 3 5 mm thickness - 62047222.G2: foreign country: new zealand.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; d9; g1; g3; g6; h1; h2; h3; h6; h10 visual examination of the returned product/provided pictures identified signs of use (nicks, gouges, scratches, wear), and confirmed the insert is fractured.All pieces returned.Dimensional analysis was performed and device was conforming to print specifications and device was submitted for sem further analysis.The analysis showed that the insert was damaged; one lateral side of the insert has been broken and the other lateral side appears to have extensive cracking and gouging, and some of the edges appear to have been possibly abraded away.One end of the insert has also been crumpled or bent as if it was pressed under a weight.Note that the hinge pin has broken and the bushing for the hinge pin is not included in the photograph.The correct alignment between the hinge pin and polyethylene insert is shown.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the available records identified the following: medical records: findings per: the surgeon used the service kit and put a new poly in because the hinged post broke and poly plug was damaged.Radiographs: hinged prosthesis right total knee arthroplasty with findings concerning for hardware failure, including fractured implant and implant disassembly.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: ZSS POLYETHYLENE INSERT XT SIZE C USE WITH DISTAL FEMORAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; .; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19528353
• Report Number: 0001822565-2024-01975
• Device Sequence Number: 15354493
• Product Code: KRO
• UDI-Device Identifier: 00889024195677
• UDI-Public: (01)00889024195677(17)290201(10)64810786
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 00585001396
• Device Lot Number: 64810786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 90 KG