MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN WAGNER CONE STEM; HIP PROSTHESIS

Model Number UNKNOWN

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported in a study to assess treatment of crowe type iv hip dysplasia, that 91 patients diagnosed with this type of dysplasia were treated with total hip arthroplasty and retrospectively evaluated by clinical and radiographic outcomes as well as complications.The study reported intraoperative femoral fracture in 2 hips without non displaced cracks during bone preparation.Both fractures in the unidentified patients were treated with titanium cables.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Investigation of this incident is currently ongoing.A followup/ final report will be submitted when additional information becomes available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: h2, h6, h10.Event description: the journal article total hip arthroplasty with the wagner cone femoral stem in patients with crowe iv developmental dysplasia of the hip: a retrospective study reports on intraoperative femoral fractures in 3 hips without nondisplaced cracks during bone preparation.Review of received data: - journal article: total hip arthroplasty with the wagner cone femoral stem in patients with crowe iv developmental dysplasia of the hip: a retrospective study complications (page 106): the intraoperative femoral fracture occurred in 3 hips without nondisplaced cracks during bone preparation.All fractures were treated with titanium cables.One of the patient with a femoral fracture underwent a femoral component revision due to nonunion at the end of the ninth month.- no medical data is available.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: - no product was returned.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification of the involved products.- dhr review: review of the device history records could not be performed due to missing reference and lot numbers.- no complaint history conducted as product and lot number are unknown.Conclusion: the journal article total hip arthroplasty with the wagner cone femoral stem in patients with crowe iv developmental dysplasia of the hip: a retrospective study reports on intraoperative femoral fractures in 3 hips without nondisplaced cracks during bone preparation.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the journal article and the information provided, no detailed assessment of the reported event could be conducted.Therefore, a definite cause could not be found.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: UNKNOWN WAGNER CONE STEM
• Type of Device: HIP PROSTHESIS
• 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: 13869524
• MDR Text Key: 287786430
• Report Number: 0009613350-2022-00171
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN WAGNER CONE PROSTHESIS
• 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: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: 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): Required Intervention