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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 03/01/2017

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

Literature article entitled "recall of the asr xl head and hip resurfacing systems" by werner maurer-ertl, md; joerg friesenbichler, md, phd; lukas a.Holzer, md, phd; lukas leitner, md, phd; kathrin ogris, md; michael maier; andreas leithner, md published online by orthopedics.2017 mar 1;40(2):e340-e347.Doi: 10.3928/01477447-20161213-04.Epub 2016 dec 20.Was reviewed for mdr reportability.The aim of the current study was to report the complications, revision rates, and implant survival of the asr devices from the authors¿ institution.Sixty-four asr devices were implanted in 56 patients (20 asr resurfacing and 44 asr xl head) between 2005 and 2008.Eight patients received a bilateral tha, in all cases an asr xl head.There were 26 female and 29 male patients, with a mean age at operation of 51 years (range, 29-68 years).Patient adverse experience include: osteolysis, infection with xl products, cystic formations, armd, dislocation, pain, high ion levels.Cup implantation ranges were 39-51 degrees for asr xl cups and 46-64 degrees for asr cups implicating malpositioned cups.Impacted products: asr (20) & asr xl (44) hip implants; corail stems (44).Revision reasons/findings for asr: serum metal ion elevation/adverse reactions to metal debris, cup malposition with subluxation, dislocation.Revision reasons/findings for asr xl: serum metal ion elevation/adverse reactions to metal debris, aseptic femoral loosening, infection, dislocation.Article reports femoral stem loosening for count of 3 asr xl heads but also reports all corail stems were left in place as it was found to be well integrated.

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.Product complaint # (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.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 rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8952836
• MDR Text Key: 161026558
• Report Number: 1818910-2019-102816
• 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: 08/13/2019

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
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 09/19/2019
• 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