MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

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

Patient Problem Atrial Fibrillation (1729)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

The literature article entitled, "retroperitoneal hematoma with bone resorption around the acetabular component after total hip arthroplasty: a case report and review of the literature" written by kenzo uchida, kohei negoro, yasuo kokubo, takafumi yayama, tsuyoshi miyazaki, hideaki nakajima, ai yoshida and hisatoshi baba published by journal of medical case reports 2012 was reviewed.The article's purpose is to report upon a case of a (b)(6) year old japanese woman who received a right-side the at age of 64 with non depuy products and then underwent left tha at age of 73 with depuy pinnacle cup and srom stem.Soon after the left tha she developed a-fib and was put on a long term regiment anticoagulant of warfarin 1.5 mg/day.Approximately 5 months later she suffered a fall that led to massive subcutaneous and pelvic girdle hematomas mostly predominantly on medial side of right thigh but no fractures, lesions or abnormal findings related to tha.A year later post fall an asymptomatic osteolytic lesion was detected on right pelvis.Two years later she complained of pain of a progressive nature in r hip during walking and radiographs revealed osteolytic lesion in r acetabulum without migration.She was still on her warfarin regimen.Upon admission to the author's hospital she demonstrated slight limited range of movement on her r side.Further assessment led to discover of massive osteolytic lesion on right side and ct images revealed the screw tip had penetrated the iliac bone from the superior exterior margin of the acetabulum.Surgeons performed revision surgery utilizing a depuy hydroxyapatite and poly-l-lactic acid super-fixorb mesh.No adverse events related to or followed the revision surgery.Adverse event associated with depuy implant products of l tha: atrial fibrillation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Additional 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 FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9250465
• MDR Text Key: 178422664
• Report Number: 1818910-2019-110867
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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 AUGMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention