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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article ¿revision of metal-on-metal hip arthroplasty in a tertiary center¿ by alexander d liddle eta al, reports on a prospective study of 39 hips with between 1 and 4 years of follow-up findings and outcomes of 39 consecutive painful mom has (in 35 patients) with median age 61 (25¿74) years between 2007 and 2010 revised in a tertiary unit (median follow-up time 30 (12¿54) months).The implants used for either resurfacing or total hip arthroplasty were: asr ¿ 6 hips (5 female patients), pinnacle ¿ 1 hip.Bhr ¿ 21 hips, cormet ¿ 5 hips, durom ¿ 1 hip, mitch ¿ 2 hips, biomet ¿ 2 hips, taperloc magnum ¿ 1 hip.Failure was happened due to following adverse factors: synovitis with negative investigations (n=3), soft tissue disruption (n=1), and solid pseudotumor (n=1).Findings were confirmed by mri.Histological examination revealed that synovitis could be suggestive of a reaction to metal debris.1 patient (2 hips) was died of an unrelated to the surgery.Asr and pinnacle were found to be associated with above reported adverse events.Case # 17 (b)(6) year-old female with asr implantation received revision.Implanted cup inclination 70 degrees and version 43 degrees.The article clarifies she received revision (per table 1 page 239).Noted are the following patient adverse event: revision surgery, severe muscle destruction to abductors and moderate muscle destruction to short external rotators (per table 2 page 240).Noted are the following product adverse events: acetabular cup - mispositioned cup & femoral head - no reported product problem.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8853715
• MDR Text Key: 153067754
• Report Number: 1818910-2019-99851
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR