MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ML TAPER STEM SZ11.0 EXT OFFSET; PROSTHESIS, HIP

Catalog Number	00771101120
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: zimmer device: 00771205600 ml taper quick connect inserter 61167474.G2 foreign: canada.H6 proposed component code: mechanical (g04)- stem.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a total hip arthroplasty, the scrub nurse was attaching the final stem to the insertion handle on the back table.The nurse felt the stem wasn't stable on the handle and pulled on the implant to check proper attachment.The implant came off with metal shards.The metal fleck was from the stem; it looks as though the insertion point on the shoulder of the implant was scored.There was a minor surgical delay (2 minutes), to grab another implant.No debris was introduced to the patient.Another stem was used and the surgeon decided to not attach the second stem onto an inserter but rather insert the stem by hand 95 percent of the way and finished seating the stem with the secondary (tear drop) impactor.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1 (unknown); h2; h3; h4; h6.Visual examination of the returned product identified indentations and gouges to the handle, strike plate, and body.Distal tip is cracked and worn.Slider pin is worn and deformed at the tip with a chamfer created.During evaluation the handle would open and close fully however the manipulation of the handle was not smooth.Stem shows scratches from attempted use.Impact hole has a chipped piece of metal at the leading hole edge.No other damage was noted.The device history record was reviewed and no discrepancies relevant to the reported event were found.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: ML TAPER STEM SZ11.0 EXT OFFSET
• Common Device Name: PROSTHESIS, HIP
• 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: 22450225
• Report Number: 0001822565-2025-02424
• Device Sequence Number: 18212916
• Product Code: JDI
• UDI-Device Identifier: 00889024131842
• UDI-Public: (01)00889024131842(17)330611(10)66020378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200823
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 00771101120
• Device Lot Number: 66020378
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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 H11.
• Patient Sex: Unknown