MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 11/13 40 +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-42-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Hypoesthesia (2352); No Code Available (3191)
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
After review of medical records, there was no revision reported.Primary surgery notes and primary surgery implant sticker sheets were provided.Orthopedic consultation report dated (b)(6) 2013 indicates that the patient had a slight leg length discrepancy on the right hip.It is not known if the implants on the right hip are from depuy.Clinic visit on (b)(6) 2013 reports lower back pain, stiffness, tingling and numbness along with right sided paravertebral muscle tenderness and a palpable muscle spasm.It was mentioned that the right hip was previously revised due to wear.Doi: (b)(6) 2010; dor: none reported (left hip).
Additional Manufacturer Narrative
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.Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ASPHERE M SPEC 11/13 40 +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: 9845933
• Report Number: 1818910-2020-08395
• Device Sequence Number: 765216
• Product Code: JDI
• UDI-Device Identifier: 10603295033769
• UDI-Public: 10603295033769
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 01/31/2015
• Device Model Number: 1365-42-600
• Device Catalogue Number: 136542600
• Device Lot Number: 3069298
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: CUP 121732058/E15S11000; HEAD 136542600/3069298; HOLE ELIMINATOR 124603000/D09110203; LINER 122140458/DR9PB1000; SCREW 121720500/428151; SCREW 121720500/CB5FT4000; SCREW 121730500/425507; SLEEVE 550524/3050310; STEM 563618/3029743
• Outcome Attributed to Adverse Event: Required Intervention