MAUDE Adverse Event Report: ZIMMER TAPER ADAPTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 650-1067

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 03/14/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient returns for a physician's visit and states that she continues to have right hip pain, especially when engaging the hip flexor.She is unable to sleep on her right side or prone.Going up and down stairs is difficult and she feels like her gait is off.She has difficulty rising from the floor without support.Competitor implants were placed during the revision, however the depuy synthes stem had remained in situ.Complaint number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TAPER ADAPTER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 17488104
• MDR Text Key: 320682260
• Report Number: MW5120827
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2023

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?: No
• Device Catalogue Number: 650-1067
• Device Lot Number: 2961013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1