MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 S-ROM 44MM M SPEC+3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-63-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Unf and medical record received.After review of medical record patient was revised to address pain.Revision notes stated that there was brownish fluid emanated from the hip joint and collection of fluid over the femoral nerve that is palpable on patient's anterior thigh in the perineal region and was able to decompress which was also the chocolate brown watery type fluid with no purulent material noted.The laboratory value of cobalt was below 7ppb.Doi: (b)(6) 2008.Dor: (b)(6) 2021.(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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11/13 S-ROM 44MM M SPEC+3
• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15850715
• Report Number: 1818910-2022-23564
• Device Sequence Number: 6393009
• Product Code: LPH
• UDI-Device Identifier: 10603295034131
• UDI-Public: 10603295034131
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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: 02/28/2012
• Device Model Number: 1365-63-500
• Device Catalogue Number: 136563500
• Device Lot Number: 2332392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2007
• 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: APEX HOLE ELIM POSITIVE STOP.; PINNACLE 100 ACET CUP 62MM.; PINNACLE MTL INS NEUT44IDX62OD.; S-ROM*SLEEVE PRX ZTT, 18F-XXL.; SROM*STM ST,36+8L NK,18X13X160.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male