MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

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

Patient Problems Thrombosis (2100); No Code Available (3191)

Event Date 02/13/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).((b)(4)) used to capture surgical intervention.  additional narrative:  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

The literature article entitled, "a minimally invasive approach for total hip arthroplasty does not diminish early post-operative outcome in obese patients: a prospective, randomised trial" written by thomas dienstknecht, christian lüring, markus tingart, joachim grifka, and ernst sendtner published by international orthopaedics (sicot) (2013) 37:1013¿1018.Doi 10.1007/s00264-013-1833-5 on 28 february 2013 was reviewed for mdr reportability.The article reports one revision for loosening of the cup in a group identified to have depuy pinnacle cups, four undisplaced fractures of the proximal femur identified to have depuy corail stems occurred during surgery and were treated with cerclages.And two cases of deep vein thrombosis were diagnosed without any therapeutic relevance during the recovery period.Adverse events: cup loosening, intraoperative fractures (interventions provided), dvt.Impacted products: depuy cup, depuy corail stem.

Manufacturer Narrative

Product complaint # (b)(4).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.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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 46581-0988 ; 6103142063
• MDR Report Key: 9143424
• MDR Text Key: 166174913
• Report Number: 1818910-2019-106905
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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 ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 11/27/2019
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention