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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Type  Injury  

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.Investigation summary.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).

Event Description

"literature article abstract entitled, ¿large-diameter metal-on-metal total hip arthroplasty: 5 years of follow-up¿ by vittorio calvisi, published in hip international (2015), ¿poster sessions¿, vol.25, suppl.1, entry p97, page s-99, was reviewed.The purpose of the article is to review the long-term outcomes of the asr-xl mom tha.Implanted depuy products: asr-xl tha including the cup, femoral head, and femoral segment.The stem used was not known but assumed to be a depuy product.Results: there were 41 revisions performed.The abstract did not provide information regarding the condition of the explanted products.All revisions had intraoperative confirmation if periarticular joint fluid consistent with foreign body reaction.All patients had elevated blood metal ions greater than 7 ppb.10 cup revisions due to migration of the cup.1 complete revision for pain and severe mobility decrease secondary to foreign body reaction and elevated blood metal ions.30 complete revisions due to elevated blood metal ions and foreign body reaction.Captured in this complaint: asr-xl cup, head, and augment: no reported product problem.Unknown femoral stem: no reported product problem.Patient harms: pain, medical device site joint range of motion decreased, elevated blood metal ions, foreign body reaction, surgical intervention, and medical device removal.There was insufficient information provided to determine of there was bearing wear on the articulating surfaces.".

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9417941
• MDR Text Key: 185224021
• Report Number: 1818910-2019-120940
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• 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