MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT STEM REMOVAL JAW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	X31-400060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hip revision, the extremity of a universal stem extractor broke when the surgeon used a slap hammer while attempting to remove a competitor stem.The portion of the extractor where the slap hammer threads in fractured when the surgeon slapped out.No backup extractor was available at the time, and the surgeon proceeded with a bone osteotomy to facilitate removal.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.The 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d10; g3; h1; h2; h3; h4; h6 visual examination of the returned product pictures identified the threaded post and the weld of the slap hammer connection component of the outer body weldment sub assembly are fractured from the outer body.The threaded rod that connects with the t-handle is bent not allowing the t-handle to fully thread along the rod.There are indentation marks, nicks, and scratches present all around the outer body weldment sub assembly.The inner and outer jaw both have wear and nicks to the teeth.The skid pad along with both screws were not returned with the device.No other damage was noted during visual evaluation.This device has an approximate field age of 10 years.Optical images of the slap hammer weld fracture surface did not reveal any clear artifacts that could indicate the failure mode.Generally, due to their altered grain structures, weld fractures often do not exhibit the typical fracture artifacts seen on forged or machined materials.However, it is suspected that the slap hammer weld fractured due to overload.Optical images of the threaded post fracture surface exhibit river lines and hinge artifacts suggesting that it was possibly fractured due to bending overload.The device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported fracture is unknown however it was identified the device was used with a competitor device; it's unknown if this off label use caused or contributed to the fracture.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: EXACT STEM REMOVAL JAW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23726302
• Report Number: 0001825034-2025-03873
• Device Sequence Number: 21495157
• Product Code: HWB
• UDI-Device Identifier: 00880304006607
• UDI-Public: (01)00880304006607(11)150924(10)427424
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/27/2026

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 Catalogue Number: X31-400060
• Device Lot Number: 427424
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown