MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SUMMIT POR TAPER SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157001110

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104)

Event Date 11/09/2011

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.

Event Description

(b)(4).Patient was revised due to pain.Doi: (b)(6) 2006 - dor: (b)(6) 2011 (side unk).**update** 7/9/2012 - litigation papers received.There is no new additional information that would affect the investigation.Left hip.Update dec 05, 2017: pfs and medical records received.In addition to what were previously alleged, pfs alleges injury, metallosis and muscle damage requiring surgical repair.After the review of medical records for mdr reportability, it was stated that the patient was revised to address pain.Revision notes reported of thin, milky fluid with some granulomatous debris, large amount of almost granulomatous inflammatory tissue and the hip was easily subluxatable anteriorly.It was also stated that the head looked like it had a little bit of wear on the dome where it might be floating on the metal acetabular shell.Clinical records reported of instability, lots of popping, bursitis and subluxation.Laboratory result for cobalt-chromium were above 7ppb.Added stem to the complaint for elevated metal ions.This complaint was updated on: december 22, 2017.

Manufacturer Narrative

(b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Additional narrative: 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.F information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ5 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7159879
• MDR Text Key: 96330049
• Report Number: 1818910-2017-52560
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295059363
• UDI-Public: 10603295059363
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

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: 07/24/2011
• Device Catalogue Number: 157001110
• Device Lot Number: A1RBLA000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 05/01/2018; 12/11/2019
• Supplement Dates FDA Received: 05/07/2018; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 65