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 Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Tissue Damage (2104); Test Result (2695); 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

A literature article was received, entitled "high prevalence of adverse reactions to metal debris in small-headed asr hips¿, by aleksi reito md, et.Al, published in clin orthop relat res (2013) 471:2954¿2961, and was reviewed by clinician for mdr reportability.The authors sought to determine the prevalence of adverse reactions to metal debris among patients who received small-headed (less than 50 mm diameter) articular surface replacement (asr) prostheses in hip resurfacing procedures, or the asr xl prostheses during thas, and identify the risk factors for adverse reactions to metal debris and if they are differ between hip resurfacing replacements compared to thas.At follow-up, of 482 hips,162 hips (34%) have been revised.The majority (85%) were revised owing to causes related to adverse reactions to metal debris.The 7-year survivorship was 51% for the asr hip resurfacing cohort and 38%for the asr xl tha cohort, respectively.Reduced cup coverage was an independent risk factor for adverse reactions to metal debris in both cohorts.High preoperative rom, use of the corail stem, and female gender were associated with an increased risk of adverse reactions to metal debris only in patients undergoing tha.Causes of revisions in asr resurfacing: number affected: adverse reaction to metal debris: 42.Infection: 1.Aseptic loosening cup: 3.Aseptic loosening stem: 0.Avascular necrosis: 1.Periprosthetic fracture (unspecified bone): 2.Pain (without adverse reaction to metal debris): 2.Causes of revisions in asr xl total hip: number affected: adverse reaction to metal debris: 42.Infection: 1.Aseptic loosening cup: 3.Aseptic loosening stem: 1.Avascular necrosis: 1.Periprosthetic fracture (unspecified bone): 2.Pain (without adverse reaction to metal debris): 2.Additionally, it was reported that pseudotumors were identified in 42 hips by cross sectional imaging.Whole blood chromium and/or cobalt level exceeded 7 ppb in 30 (18%) patients who had unilateral hip resurfacing and in 115 (37%) patients who had unilateral tha.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 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 road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8749472
• MDR Text Key: 149679042
• Report Number: 1818910-2019-97252
• 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,Followup
• Report Date: 06/11/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 06/11/2019; 08/28/2019
• Supplement Dates FDA Received: 07/02/2019; 09/03/2019
• 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