MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ9 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-02-165
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/03/2021
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 the medical records the patient was revised to address metalosis and elevated metal ions.Operative note reported metal debris around the trunnion.There were tiny scratches covering the surface of the femoral head.Darkening of the tissues consistent with metalosis were seen.There was a large area of osteolysis in the acetabulum.Liner was found to have a very tiny scratches and soft tissue and this was sent for pathology.Total extraction of the liner from the cup took over an hour.Doi: (b)(6) 2010; dor: (b)(6) 2021 ; 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 : 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 SZ9 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: 12121675
• Report Number: 1818910-2021-14332
• Device Sequence Number: 3712741
• Product Code: LPH
• UDI-Device Identifier: 10603295059509
• UDI-Public: 10603295059509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 06/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-02-165
• Device Catalogue Number: 157002165
• Device Lot Number: B17DEA000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 12/14 ARTICUL 40MM M SPEC+5; BONE PUTTY OSTEOSURGE; PINNACLE MTL INS NEUT40IDX58OD; PINNACLE SECTOR II CUP 58MM; SUMMIT DUOFIX TAP SZ9 STD OFF; 12/14 ARTICUL 40MM M SPEC+5; BONE PUTTY OSTEOSURGE; PINNACLE MTL INS NEUT40IDX58OD; PINNACLE SECTOR II CUP 58MM; SUMMIT DUOFIX TAP SZ9 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR