MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN WAGNER STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: iran.Hadi ravanbod, kaveh gharanizadeh, peyman mirghaderi, ahmad hassan, mansour abolghasemian.(2023) subtrochanteric shortening osteotomy provides superior function to trochanter slide osteotomy in tha for patients with unilateral crowe type iv dysplasia at a minimum of 3 years.Pgs.1-10.Doi 10.1097/corr.0000000000002900.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 mdr will be submitted.

Event Description

It was reported in a journal article that 5 patients who underwent trochanteric slide osteotomy (tso) sustained a nonunion at the osteotomy site; of which, two patients had greater trochanter migration of less than 2cm with a slight limp.No further treatment was provided.

• Brand Name: UNKNOWN WAGNER STEM
• 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: 19215794
• MDR Text Key: 341422330
• Report Number: 0009613350-2024-00154
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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: UNKNOWN
• 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: 04/03/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other