MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 11/13 36 -3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-26-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fatigue (1849); Pain (1994); Ambulation or Postural Difficulties (2544); Muscle/Tendon Damage (4532)
Date of Event	05/06/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine the legal contact information.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 medical records received.After review of medical record, patient was revised to address left hip abductor avulsion.Patient had pain, limp and weakness in left hip.Patient had left abductor failure and abduction.There was scar tissue between the abductors and the musculotendinous cuff.Doi: (b)(6) 2012.Dor: (b)(6) 2014; (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: per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• Brand Name: ASPHERE M SPEC 11/13 36 -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
• MDR Report Key: 11011892
• Report Number: 1818910-2020-26961
• Device Sequence Number: 19819570
• Product Code: JDI
• UDI-Device Identifier: 10603295033233
• UDI-Public: 10603295033233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• 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): 11/24/2020

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: 1365-26-100
• Device Catalogue Number: 136526100
• Device Lot Number: 3276573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: ALTRX NEUT 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 11/13 36 -3; PINNACLE 100 ACET CUP 52MM; S-ROM*SLEEVE PRX ZTT, 16D-SML; UNKNOWN HIP FEMORAL STEM; ALTRX NEUT 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 11/13 36 -3; PINNACLE 100 ACET CUP 52MM; S-ROM*SLEEVE PRX ZTT, 16D-SML; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR