MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL INSERTER/EXTRACTOR

Model Number 31-302000592008

Device Problems Break (1069); Difficult to Remove (1528); Activation Problem (4042)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 01/25/2022

Event Type  Injury  

Event Description

Threads of zimmer biomet femoral inserter/extractor broke during revision of l posterior total hip replacement.A 13/50 trial stem was placed.The proximal reamer was used.Attempt to place the proximal body trial but it would not engage.The threaded attachment of the extractor broke off during attempts to remove the distal trial extractor.Following proximal fracture near the level of midshaft.Fda safety report id# (b)(4).

• Brand Name: FEMORAL INSERTER/EXTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 13424788
• MDR Text Key: 285012917
• Report Number: MW5107128
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31-302000592008
• Device Lot Number: B31-300-813689280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Disability; Other
• Patient Age: 57 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic