MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Not Applicable (3189); 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.(b)(4).

Event Description

An article ¿cementation and interface analysis of early failure cases after hip-resurfacing arthroplasty¿ by matthias krause et al reports on cementation and interface analysis of 150 early failure cases (64 men - mean age 56.4 years±9.2 and 63 women - mean age 55.5 years±10.4) after hip-resurfacing arthroplasty between 2004 and 2007.All patients underwent to revision surgery due to early failure (mean time to failure averaged 8.3months±11.0) and used following implant type: biomet: recap (7), corin: cormet (15), depuy: asr (110), s&n: bhr (7), zimmer: durom (11).Reasons of revision surgery were reported in 92 of 110 asr (depuy) cases: 73 (80%) failed due to atraumatic periprosthetic fracture, 5 (5%) were revised for acetabular component loosening and 14 (15%) for others such as pain or luxation of the femoral component.No clarification was found on which events were specifically present on specific patients.Eleven cases showed major cement-mantle defects, most likely caused intraoperatively by bleeding, folded cement layers or trapped air.Implant design also had a substantial influence on cement penetration.Multivariate analysis confirmed significant independent differences in penetration between male and female patients.In specimens from women, cement penetration was significantly deeper than in men in zone 1 and zone 2.Zone 3 showed no significant differences.Fifty-nine cases had a fibrous membrane causing pseudoarthrosis at the cement¿bone interface.This membrane was significantly thicker in cases with osteonecrosis compared to cases viable bone.Poor cementation was observed as an adverse factor for above mentioned adverse events; however, the cause of the failures was obviously multifactorial.

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.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, 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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8825950
• MDR Text Key: 152175339
• Report Number: 1818910-2019-99189
• 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
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• 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
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention