MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 40 +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-05-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Osteolysis (2377); Test Result (2695); Fibrosis (3167); No Code Available (3191)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information for the initial reporter once the details are provided.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 Description

Medical records received.After review of medical records patient was revised to addressed failed metal on metal left total hip replacement with elevated cobalt, synovitis/fibrosis.Operative notes indicated pain, osteolysis and pseudotumor.Doi: (b)(6) 2010 dor: (b)(6) 2018 left hip.Please see (b)(4) for right hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer 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.

• Brand Name: ASPHERE M SPEC 12/14 40 +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10580876
• MDR Text Key: 208361655
• Report Number: 1818910-2020-20843
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295032977
• UDI-Public: 10603295032977
• Combination Product (y/n): N
• PMA/PMN Number: K082585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2020

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: 03/31/2015
• Device Model Number: 1365-05-100
• Device Catalogue Number: 136505100
• Device Lot Number: 3089015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 09/25/2020; 10/28/2020
• Supplement Dates FDA Received: 09/30/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD; SUMMIT POR TAPER SZ5 STD OFF; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD; SUMMIT POR TAPER SZ5 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR