MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

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

Event Date 05/06/2020

Event Type  malfunction  

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, "biological monitoring of metal ions released from hip prostheses" written by annamaria nicolli, andrea trevisan, isabella bortoletti, assunta pozzuoli, pietro ruggieri, andrea martinelli, alberto gambalunga, and mariella carrieri published by international journal of environmental research and public health published 6 may 2020 was reviewed.The article's purpose was to evaluate the levels of different isotypes include co and cr levels in urine of two groups of patients with two different types of metal-on-metal (mom) total hip prostheses depuy asr in group a (25 patients) in non-depuy in group b.The measurements in group a with depuy products were measured at 9 years.The article these patients had not received any revision or treatment for the increased levels detected in the samples at the time of the article's compilation.The article associates the elevated ion levels to wear from the mom bearing material release metal particles into blood and urine.The article's test results are based upon urine samples.Femoral stem is not identified.Depuy products: asr xl head, asr xl sleeve, asr xl cup.Adverse events: elevated ion levels attributed to bearing wear (treatment not indicated and no further information provided.

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 FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10305648
• MDR Text Key: 233707922
• Report Number: 1818910-2020-16463
• 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,literature
• 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 FEMORAL HEAD
• 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