MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD CERAMIC; CERAMIC FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD CERAMIC

Device Problem Noise, Audible (3273)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "persistent noise after ceramic-on-ceramic total hip replacement due to bearing coupling size mismatch: a case report" written by chee-ken chan, dong-hyun lee, taek-rim yoon, and kyung-soon park published by journal of orthopaedic science 2017 was reviewed.The article's purpose was to report on a case study of a 61 yo male with received a l tha with depuy aml hip system and ceramic on ceramic head and liner.The patient reported noise for a continuous 3 years with no evidence of patient harm or discomfort.No product defects could be detected radiographically.Figure 1 provides further detail that radiographic detection of subsidence of the stem approximately 10 mm occurred 3 years post implantation leading to limb asymmetry (as narrative description details).Patient opted voluntarily for exploratory surgery and intraoperative the femoral ceramic 32 mm head was determined mismatched with 36 mm diameter liner.The femoral head was exchanged to a 36 mm ceramic head with metal sleeve and long neck.There was no evidence of stripe, debris or impingement.Patient recovered well and reported as very satisfied as the problem of noisy hip and leg shortening was now resolved.Depuy products: aml stem, ceramic head, ceramic liner, depuy cup.Adverse events: audible noise (determined to be femoral head within the liner).Limb asymmetry (treated by revision).Stem subsidence (treated by revision surgery).

• Brand Name: UNK HIP FEMORAL HEAD CERAMIC
• Type of Device: CERAMIC FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11056304
• MDR Text Key: 241251992
• Report Number: 1818910-2020-27480
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

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: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD CERAMIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention