MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 44MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-62-000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Synovitis (2094); Discomfort (2330); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	08/23/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.(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
Pinnacle medical records received.After review of medical records the patient was revised to addressed infected right total hip arthroplasty and extensive metallosis/alval reaction from metal on metal articulation with extensive tissue inflammation.Operative findings thick purulent material anterior and posterior hips, as well as osteolysis at the proximal femur and acetabulum.Also indicated pain, discomfort and swelling.A moderate amount of bursitis, synovitis, bone loss, debris as well.Doi: (b)(6) 2008.Dor: (b)(6) 2012.(right hip).
Additional 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.
Additional 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.E3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Litigation alleges elevated metal ions.Doi: (b)(6) 2008, dor: (b)(6) 2012, (right hip).
Additional 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: 12/14 ARTICUL 44MM M SPEC+5
• Common Device Name: 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: 10471118
• Report Number: 1818910-2020-19040
• Device Sequence Number: 2147454
• Product Code: JDI
• UDI-Device Identifier: 10603295034070
• UDI-Public: 10603295034070
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2012
• Device Model Number: 1365-62-000
• Device Catalogue Number: 136562000
• Device Lot Number: 2400591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/12/2020; 10/30/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/09/2020; 10/22/2020; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT44IDX62OD; PINNACLE SECTOR II CUP 62MM; TRI-LOCK BPS SZ 5 STD OFFSET; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT44IDX62OD; PINNACLE SECTOR II CUP 62MM; TRI-LOCK BPS SZ 5 STD OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR