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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/14/2011

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.(b)(4).

Event Description

The literature article entitled, "midterm results of uncemented acetabular reconstruction for posttraumatic arthritis secondary to acetabular fracture" written by oujie lai, md, jing yang, md, bin shen, md, zongke zhou, md, pengde kang, md, and fuxing pei, md published by the journal of arthroplasty vol.26 no.7 2011 accepted by publisher 14 february 2011 was reviewed.The article's purpose is to evaluate the midterm results of using uncemented acetabular components to treat posttraumatic arthritis after acetabular fracture.Data was compiled from 31 patients (22 men 9 women age range of 27-74 years) with follow up 1,2,3, 6 and 12 months post implantation and annually after.Depuy and non-depuy products were utilized.The article does not identify which specific products were associated with the adverse events.The article does not provide adequate information to determine accurate quantities.Depuy products utilized: duraloc cups, aml stems, femoral heads (material unknown), poly liners adverse events: administration of blood transfusions reports of pain patient fall causing a dislocation (treated by closed reduction) dislocation due to an improper body position (treated by closed reduction) sciatic nerve injury (treated by surgical sciatic nerve release) implant site hematoma (treated by surgical evacuation) cup migration (radiographically detected without indication of treatment).

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.H10 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.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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9607718
• MDR Text Key: 186201080
• Report Number: 1818910-2020-02294
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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: 01/07/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention