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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2022

Event Type  Injury  

Event 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.

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.

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 Description

No change to previously reported event.

• Brand Name: WAGNER SL REVISION®, SCREW FOR TRIAL STEM, L 265
• Type of Device: 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
• MDR Text Key: 290659898
• Report Number: 0009613350-2022-00267
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024277977
• UDI-Public: 00889024277977
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/03/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male