MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 11/13 36 +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-31-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Pcf and medical records received.After review of medical records, patient was revised to address left hip modular metal-on-metal total hip arthroplasty with adverse local tissue reaction and possible metal toxicity.Patient has developed left hip pain and mild abductor irritation but no severe weakness.Laboratory studies showed that patient had elevated serum metal ion levels with cobalt greater than 8 and chromium greater than 4.Operative notes stated that upon entry into the joint, there was expression of only a very scant amount of clear, benign-appearing straw-colored joint fluid.There were a few, patchy areas of dark gray to black stained synovium but the majority of the periprosthetic synovial soft tissues were noted to be grossly healthy appearing without granulation, friability, or necrosis.There was no gross evidence of infection.Doi: (b)(6) 2010.Dor: (b)(6) 2019 (left hip).Patient was bilateral.See (b)(4) for the right hip.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ASPHERE M SPEC 11/13 36 +0
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9843411
• Report Number: 1818910-2020-08313
• Device Sequence Number: 16328781
• Product Code: JDI
• UDI-Device Identifier: 10603295033370
• UDI-Public: 10603295033370
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 03/31/2015
• Device Model Number: 1365-31-100
• Device Catalogue Number: 136531100
• Device Lot Number: 3106522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR