MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ8 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
Event or Problem Description
Asr medical records received.The patient was implanted with asr xl.It was also reported that the patient had a revision surgery however there were no reason or revision notes provided.After review of medical records patient was revised to addressed failed right total hip arthroplasty secondary to mechanical complications of metal on metal hip replacement.Prior to revision patient alleged pain, elevated cobalt and chromium levels.There was some metallosis along the trunnion.Doi: (b)(6) 2007; dor: (b)(6) 2020; right hip.

• Brand Name: SUMMIT POR TAPER SZ8 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12120646
• Report Number: 1818910-2021-14299
• Device Sequence Number: 3768236
• Product Code: LPH
• UDI-Device Identifier: 10603295060093
• UDI-Public: 10603295060093
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 06/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1570-11-150
• Device Catalogue Number: 157011150
• Device Lot Number: BB8CR1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/06/2021
• 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: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT POR TAPER SZ8 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR