MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (PS) LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42512400710
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an articular surface and tibial tray would not assemble.The surgeon tried to insert the liner and lock with an insert gun, but the insert would not lock down.The surgeon washed and cleaned up before inserting the liner again.There was no tissue or cement in the tibia or blocking the insert from going in but was still unable to lock down the insert.As a last resort, the surgeon tried to punch the insert in with a tibia punch with inwards and downwards direction, and there was still a big gap between the insert and tibia.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).G2: singapore.H3: customer has indicated that the product will 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, and h11.Corrected: h4.Visual examination of the returned product identified signs of attempted implant assembly with damage and gouges visible around the inserter/extractor slot, along with outer rail damage.The dovetail (locking feature) was found to be flared out.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed.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: ARTICULAR SURFACE FIXED BEARING (PS) LEFT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22123437
• Report Number: 3007963827-2025-00221
• Device Sequence Number: 7484415
• Product Code: MBH
• UDI-Device Identifier: 00889024237247
• UDI-Public: (01)00889024237247(17)300119(10)67109590
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42512400710
• Device Lot Number: 67109590
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2025
• 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
• Patient Sex: Unknown