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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Test Result (2695); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.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
Medical records received.After review of medical records patient alleges pain and elevated cobalt.Doi: (b)(6) 2011.Dor: none reported right hip.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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: ASPHERE M SPEC 12/14 40 +1.5
• 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: 10580793
• Report Number: 1818910-2020-20834
• Device Sequence Number: 3110235
• Product Code: JDI
• UDI-Device Identifier: 10603295032977
• UDI-Public: 10603295032977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 1365-05-100
• Device Catalogue Number: 136505100
• Device Lot Number: 3140559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/25/2020; 10/28/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 09/30/2020; 10/29/2020
• 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: ASPHERE M SPEC 12/14 40 +1.5.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN SECTOR W/GRIPTION 56MM.; PINNACLE MTL INS NEUT40IDX56OD.; ASPHERE M SPEC 12/14 40 +1.5; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD
• Outcome Attributed to Adverse Event: Required Intervention