MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 36 +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-53-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Discomfort (2330)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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 claim submission form and medical record received.After review of medical record, patient was revised to address metallosis.Revision notes stated that a rush of fluid was seen which was brown and consistent with metal reaction fluid.The head was disimpacted from the trunnion and there was shown to be corrosion on the trunnion itself.Liner was removed.Patient experienced pain and discomfort.Doi: (b)(6) 2010.Dor: (b)(6) 2020; (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.Device history lot: per wi-3430 it has been determined that an mre is not required.

• Brand Name: ASPHERE M SPEC 12/14 36 +8.5
• 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: 11122938
• Report Number: 1818910-2021-00381
• Device Sequence Number: 767193
• Product Code: JDI
• UDI-Device Identifier: 10603295033967
• UDI-Public: 10603295033967
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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 Model Number: 1365-53-100
• Device Catalogue Number: 136553100
• Device Lot Number: 2977677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/08/2021
• 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: 6IN AML SM STATURE 12.0MM; ASPHERE M SPEC 12/14 36 +8.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 52MM; PINNACLE MTL INS NEUT36IDX52OD; 6IN AML SM STATURE 12.0MM; ASPHERE M SPEC 12/14 36 +8.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 52MM; PINNACLE MTL INS NEUT36IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 85