MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 40; BONE SCREWS AND PINS : SCREWS

Catalog Number	125740000
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Ppf and medical records receive.Ppf alleged loosening of the cup, dislocation, and elevated metal ions.After review of the medical records, the patient was revised to address the loosening of acetabular component, soft tissue loss, metallosis, and dislocation.Operative note reported of massive soft tissue destruction and broken 2 screws.There was no lot number provided for the broken screws.Doi: (b)(6) 2012.Dor: (b)(6) 2016, (right hip).Fourth revision.(b)(4), (right hip) 1st revision.(b)(4), (right hip) 2nd revision.(b)(4), (right hip) 3rd revision.
Additional 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.Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 40
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9204467
• Report Number: 1818910-2019-108927
• Device Sequence Number: 3031368
• Product Code: LPH
• UDI-Device Identifier: 10603295019893
• UDI-Public: 10603295019893
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 125740000
• Device Lot Number: D3TES4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR