MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CRUCIATE RETAINING POLY BEARING 12MM; PROSTHESIS, KNEE

Catalog Number	42512000512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthrofibrosis (4885)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D2, d4, g4: diligence is in process to provide product identification information; however, no further information has been provided at this time.D10: unknown tibial component lot # unk.Unknown femoral component lot # unk.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.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 the patient underwent a knee replacement on an unknown date.Subsequently, the patient was revised due to stiffness and soft tissue contraction.During the revision a smaller sized poly was installed.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2; a3a; b1; b2; b5; d1; d2a; d2b; d4; d6a; e1; e2; g1; g3; g4; h1; h4; h6.The following sections were updated: b5; d4; g3; g4; h6; h11.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.The reported products were reviewed for compatibility with no issues noted.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: CRUCIATE RETAINING POLY BEARING 12MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22991025
• Report Number: 0001822565-2025-03314
• Device Sequence Number: 21034252
• Product Code: MBH
• UDI-Device Identifier: 00889024235137
• UDI-Public: (01)00889024235137(17)240831(10)64517712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 42512000512
• Device Lot Number: 64517712
• Was Device Available for Evaluation?: No
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 08/15/2025; 10/23/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/06/2025; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male