MAUDE Adverse Event Report: BIOMET, INC. PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 01/01/2000

Event Type  Injury  

Event Description

Reporter calling, stating she has problems with chronic pain and nerve damage as a result of three hip surgeries.Reporter states "i don't want to go through another hip implant again" due to these problems, and expresses concern if the biomet hips are possibly under recall.Reporter states she previously returned one of the hips to the manufacturer "for evaluation" but they have never contacted her back."lot: 316860, lot: 244490, lot: 141660, ref: (b)(4), ref: (b)(4)." reference reports: mw5146596, mw5146598.

• Brand Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 17876949
• MDR Text Key: 325335807
• Report Number: MW5146597
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/04/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female