MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL HIP STEM, UNCEMENTED, ø 22/225, TAPER 12/14; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/11/2024

Event Type  Injury  

Event Description

It was reported a patient had an initial right total hip arthroplasty in (b)(6) 2014 followed by a revision in (b)(6) 2015 due to loosening.Later on, (b)(6) 2023, underwent a second revision for metallosis and a fractured stem.Subsequently, on (b)(6) 2024, fell and experienced a femoral periprosthetic fracture.Approximately one month ago, underwent an additional procedure where a stable double plate osteosynthesis was performed.It is unclear at this time if implants were revised as no further details have been provided.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).G2.Report source: germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported a patient had an initial right total hip arthroplasty followed by a revision approximately 14 months later due to loosening.Later, approximately 8 years later, a second revision was performed for metallosis and a fractured stem.Subsequently, approximately 1 month later, the patient fell and experienced a femoral periprosthetic fracture and underwent an additional procedure where a stable double plate osteosynthesis was performed.It is unclear at this time if implants were revised as no further details have been provided.Diligence is complete and no further information on the reported event have been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, d1, d4, g3, g4, g6, h2, h3, h6, h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Review of the complaint history found no additional related complaints for this item.Based on the available information it can be concluded that the reported event is most likely due to the fall of the patient.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.

• Brand Name: WAGNER SL HIP STEM, UNCEMENTED, ø 22/225, TAPER 12/14
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18730414
• MDR Text Key: 335728698
• Report Number: 0009613350-2024-00051
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K200112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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: 0100102222
• 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: 01/23/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 89 KG