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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 03/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(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

Literature article entitled, ¿damage patterns at the head-stem taper junction helps understand the mechanisms of material loss¿ by harry s.Hothi, et al, published by the journal of arthroplasty (2012), vol.32, pp.291-295, was reviewed.The purpose of this article was to review the bearing wear and corrosion patterns of explanted mom components following revision surgery due to aseptic loosening or unexplained pain.Implanted products: the authors studied 155 mom thas.The depuy products included in this study were: 18 pinnacle cup and metal liners, 26 asr-xl thas, 35 corail stems, and 7 s-rom stems with a sleeve.The remaining implants were competitor products.Every implant was studied after explantation.The reasons for revision surgery giver were unexplained pain and aseptic loosening.At revision surgery, an unidentified number of cups and stems were confirmed mispositioned.The explanted products were examined macro and microscopically for evidence of corrosion and bearing wear.The authors note that many patients had elevated blood metal ions.They provide the mean levels with a range (co mean 7.4 (0.6-212.4 ppb) and cr.Mean 3.5 (0.2-111 ppb).Results: the authors do not provide results by manufacturer.All findings were grouped together as a whole.This complaint captures all o f the findings listed in the text.Corrosion was seen on the taper junctions of both the head and stem.This was identified by black debris and microscopic evidence of fretting and noticing on both component surfaces.Bearing wear was extensive and found on the all articulating surfaces.This was identified visually and microscopically.Captured in this complaint: 18 metal pinnacle cups for misposition and loosening, 18 metal pinnacle liners for bearing wear, 18 cocr femoral heads for taper corrosion and bearing wear, 26 asr cups for misposition, loosening, bearing wear, asr femoral head for bearing wear and corrosion, asr augment for loosening and misposition, 35 corail stems for loosening, mispositioning, and taper corrosion, 7 s-rom stems and augments for corrosion at taper, implant loosening, and implant mispositioned.

• 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
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9288034
• MDR Text Key: 180982463
• Report Number: 1818910-2019-111675
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/14/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention