MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011135

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Inflammation (1932); Necrosis (1971); Pain (1994); Scarring (2061); Tissue Damage (2104); Test Result (2695); No Code Available (3191)

Event Date 06/01/2015

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).Occupation: attorney.

Event Description

Litigation alleges patient was revised to address pain, metallosis, granulomatous debris, necrosis, pseudotumor and inflammation.Update jun 30, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges abscess.After review of the medical records for mdr reportability, revision note stated that there was a 4cm wound, extensive scarring, and the pseudotumor mass measured approximately 15x6x7cm, mass was cystic in its central portion.Update ad 25 jun 2018: receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear and elevated metal ions.Added patient's age, account name and patient harms.

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: corrected: h6.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 will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8381621
• MDR Text Key: 137519114
• Report Number: 1818910-2019-86150
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060086
• UDI-Public: 10603295060086
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

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: 157011135
• Device Lot Number: Y51CN1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• 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
• Patient Age: 75 YR
• Patient Weight: 113