MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +0; HIP FEMORAL HEAD

Catalog Number 136531000

Device Problems Material Disintegration (1177); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Synovitis (2094)

Event Date 02/22/2011

Event Type  Injury  

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Pfs and medical records received.This complaint is legal.Pfs alleges pain, trouble walking, and trouble performing daily activities.The patient had a revision operation on (b)(6) 2011 due to metallosis, synovitis, and pain.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

In addition to previous allegations, ppf alleges metal wear.

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 associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: S-ROM M HEAD 36MM +0
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4459259
• MDR Text Key: 13090892
• Report Number: 1818910-2015-12075
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/31/2014

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 Expiration Date: 02/25/2007
• Device Catalogue Number: 136531000
• Device Lot Number: YGC44
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided; 01/25/2019; 09/12/2019
• Supplement Dates FDA Received: 03/19/2015; 01/28/2019; 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 90