MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problems Test Result (2695); No Code Available (3191)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The literature article entitled, "prevalence of subclinical cardiac abnormalities in patients with metal - on- metal hip replacements" written by f.Lodge, r.Khatun, r.Lord, a.John, a.G.Fraser, and z.Youse published by international journal of cardiology made available online 17 may 2018 was reviewed.The article's purpose: "we therefore performed a cross-sectional study of orthopaedic patients who had received mom hip prostheses to: a) ascertain the prevalence of overt cardiomyopathy and b) evaluate any relationship between subclinical markers of cardiac dysfunction and levels of plasma cobalt and chromium." data set was compiled from 95 mom hip patients and 15 controls with non mom hip prostheses.It is noted that depuy products are listed with non-depuy products utilized for mom prostheses.Article reports 18 patients had undergone prosthesis removal with average of 611 days post implantation.Article reports increased plasma cobalt level was associated with increasing heart size but "subjects had no evidence of myocardial dysfunctions in regards to the cardiac aspect of the study.It is noted that patients had elevated cobalt (co) and chromium (cr) levels.The article associates elevated ion levels to the metal on metal bearing surfaces articulation releasing metal related particles.The article does not provide clarification on which specific products are associated with specific adverse events.Depuy products: corail stem, pinnacle cup, metal liner, metal head.Adverse events: removal of prosthesis.Elevated ion levels.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10303599
• MDR Text Key: 208203459
• Report Number: 1818910-2020-16444
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention