MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ8 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-02-150
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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/30/2020
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.
Event or Problem Description
Unf and medical records received.After review of medical records patient was revised to addressed mechanical failure of prosthetic joint, painful right total hip arthroplasty with elevated metal ions cobalt.Operative notes reported, the patient had a large fluid collection throughout his right hip joint and a large soft tissue lesion consistent with metal debris.Doi: (b)(6) 2004; dor: (b)(6) 2020; (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.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT DUOFIX TAP SZ8 STD 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: 11913884
• Report Number: 1818910-2021-11455
• Device Sequence Number: 19179727
• Product Code: LPH
• UDI-Device Identifier: 10603295059493
• UDI-Public: 10603295059493
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 05/24/2021

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: 1570-02-150
• Device Catalogue Number: 157002150
• Device Lot Number: YH5DL1000
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT36IDX56OD; SUMMIT DUOFIX TAP SZ8 STD OFF; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT36IDX56OD; SUMMIT DUOFIX TAP SZ8 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR