MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH WAGNER SL REVISION, TRIAL STEM, DISTAL, 19; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical device: wagner sl revision screw for trial stem, l 265; item#: 0100109806, lot#: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00267.The product was 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 surgery the locking screw of the trial stem broke leaving the distal segment of the stem in the femur.An extended trochanteric osteotomy had to be performed to extract the distal segment of the stem.Surgery was extended by between an hour to 90 minutes due to the osteotomy.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product showed that the distal trial stem has several nicks and scratches on all outer surfaces.A hole has been drilled in the proximal half of the trial stem.The proximal coupling of the trial stem is worn and shows instrument marks.The broken off part of the trial screw is still in the distal trial stem.The other part of the screw was accidentally thrown away and cannot be returned.The reported event can be confirmed.A definitive root cause cannot 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, TRIAL STEM, DISTAL, 19
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14433039
• Report Number: 0009613350-2022-00287
• Device Sequence Number: 5579038
• Product Code: LXH
• UDI-Device Identifier: 00889024277854
• UDI-Public: (01)00889024277854(11)141204(10)14.085107
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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 Model Number: N/A
• Device Catalogue Number: 01.00109.119
• Device Lot Number: 14.085107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male