MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION®, SCREW FOR TRIAL STEM, L 265; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the trial locking screw broke leaving the distal segment of the stem in the femur.An eto (extended trochanteric osteotomy) had to be performed to extract the distal segment of the wagner sl stem.Patient involvement - more complex surgery.
Additional Manufacturer Narrative
Medical product: biolox® delta, ceramic femoral head, l, 40/+3.5, taper 12/14 catalog#: 00-8775-040-03 ; lot#: 2933958.Wagner sl revision stem 19/265 catalog#: 01.00102.619; lot#: 3059866.G7 longevity neutral 40mm h catalog#:20104008 ; lot#: 64994663.G7 pps ltd acet shell 64h catalog#: 01.0000.669 ; lot#: 6129815.Bone scr 6.5x35 self-tap catalog#: 00625006535; lot#: 65120781.Bone scr 6.5x25 self-tap catalog#: 00625006525; lot#: j7051450.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).In transit to manufacturer.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4 serial number unknown.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: WAGNER SL REVISION®, SCREW FOR TRIAL STEM, L 265
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 14277784
• Report Number: 0009613350-2022-00267
• Device Sequence Number: 4841551
• Product Code: JDI
• UDI-Device Identifier: 00889024277977
• UDI-Public: 00889024277977
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00109.806
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 04/03/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male