MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION®, SCREW FOR TRIAL STEM, L 305; PROSTHESIS, HIP

Catalog Number	0100109807
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item # 0100109114, wagner sl revisionâ®, trial stem, distal, 14, lot # 4504160664.G2: report source germany.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 kit inspection, it was noted that the thread of the rod is broken off in the shaft.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Instrument was returned for evaluation.The instrument ref 01.00109.807 shows severe damage to the front thread section.The thread is highly deformed.Signs of use can be identified on the shaft area.The hex socket also shows signs of use.No indications of a fracture were observed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.Reported event did not occur in an operating room or as part of a medical procedure; therefore, no medical records are available for review.Based on the performed investigation the reported event can be confirmed.The investigation revealed that the front thread on the instrument ref 01.00109.807 is highly deformed and damaged, and therefore no longer fulfills its function.It is unknown how and where/when this event occurred and a definitive root cause could not be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: WAGNER SL REVISION®, SCREW FOR TRIAL STEM, L 305
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21892183
• Report Number: 0009613350-2025-00334
• Device Sequence Number: 12800572
• Product Code: JDI
• UDI-Device Identifier: 00889024277984
• UDI-Public: (01)00889024277984(10)4504502792
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191781
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 0100109807
• Device Lot Number: 4504502792
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown