MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 36 +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-52-100
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/06/2019
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
Unfiled claim and pinnacle mom medical records received.After review of the medical records the patient was revised due to metal wear and corrosion and pain.Operative note reported taper junction corrosion at the stem.There was joint fluid visible as bursal fluid, slightly gray color suggestive of metal staining, corrosion both in neck and the taper of the head.However there was no gross wear of the articulating surface.Pathology report minor corrosion to neck of femoral component, proteinaceous material between cup and liner, bursa over the greater troch.Doi: (b)(6) 2011; dor: (b)(6) 2019 ; left 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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: ASPHERE M SPEC 12/14 36 +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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12916128
• Report Number: 1818910-2021-26909
• Device Sequence Number: 20139398
• Product Code: KWA
• UDI-Device Identifier: 10603295033943
• UDI-Public: 10603295033943
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 11/30/2015
• Device Model Number: 1365-52-100
• Device Catalogue Number: 136552100
• Device Lot Number: 3224295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AML SM STATURE 16.5MM; ASPHERE M SPEC 12/14 36 +5; PINN SECTOR W/GRIPTION 52MM; PINNACLE MTL INS NEUT36IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White