MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 5.0MM DIA TPRD HD PER SCRW 55; BONE SCREWS AND PINS : SCREWS

Catalog Number	125755000
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	04/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Pfs alleges pain, instability, and recurrent abscesses, and using cane for mobility.After review of medical records, patient was revised to address aseptic loosening.Gross pathology reported of a large volume synovial fluid with consistent synovitis, metallosis, metallic debris, broken rim fit screw only one of four screw screw, gross loosening of cup.Operative report cup had a vertical altitude with gross anteversion and had migrated.Loosening confirmed.One broken screw were readily identified as broken involving the lipped portion of the cup and demonstrated with gross metallosis and gray stained.Doi: (b)(6) 2012; dor: (b)(6) 2014; (right hip).
Additional Manufacturer Narrative
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, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 55
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8435667
• Report Number: 1818910-2019-87799
• Device Sequence Number: 2051583
• Product Code: JDI
• UDI-Device Identifier: 10603295019923
• UDI-Public: 10603295019923
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K861979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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 Catalogue Number: 125755000
• Device Lot Number: BC5A54000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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: Other
• Patient Age: 72 YR