MAUDE Adverse Event Report: ZIMMER ZIMMER M/L TAPES HIP PROSTHESIS; FEMORAL STEM

Catalog Number 7711-09-10

Device Problems Corroded (1131); Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Reaction (2414)

Event Date 04/29/2010

Event Type  No Answer Provided  

Event Description

Problem: a failed totally hip arthroplasty may be caused by mechanically assisted crevice corrosion or macc.This occurs at the metal/metal modular junction in a total hip arthroplasty and has serious consequences such as adverse local tissue reaction (altr) in patients with metal-on-polyethylene total hip replacement.This patient had characteristics of macc.This clinical complication is extremely concerning because of both the high volume of hip replacements worldwide as well as the extensive soft tissue damage that can occur with severe reactions.Left total hip replacement.Patient: (b)(4).Acct $: (b)(6).Diagnosis: djd hip.Lot # 61417334m edi: (b)(4), ref (b)(4), trilogy acetabular system, shell with cluster holes; lot 61436662, edi: 00625006525, bone screw self-tapping; lot 61342519, edi: (b)(4), ref: (b)(4), trilogy acetabular system, liner, standard.

• Brand Name: ZIMMER M/L TAPES HIP PROSTHESIS
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 7218755
• MDR Text Key: 98426049
• Report Number: MW5074865
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 7711-09-10
• Device Lot Number: 61389207
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR