MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ10 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-01-180
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Asr ppd and medical records received.After review of medical records patient was revised to addressed failed left total hip replacement secondary to local tissue reaction, associated with metal on metal.There was relatively large contained lytic lesion in the inferior aspect of the acetabulum.Amount of fluid and pseudotumor in the hip joint.There was a taper corrosion that extended distal to the taper which extended beyond the neck of the femoral component, that is the corrosion extended outside of the taper.Doi: (b)(6) 2007.Dor: (b)(6) 2020; 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 POR TAPER SZ10 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: 11863911
• Report Number: 1818910-2021-10942
• Device Sequence Number: 11678405
• Product Code: LPH
• UDI-Device Identifier: 10603295059417
• UDI-Public: 10603295059417
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• 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): 05/11/2021

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: 1570-01-180
• Device Catalogue Number: 157001180
• Device Lot Number: ZE6D71000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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 +8; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; SUMMIT POR TAPER SZ10 STD OFF; ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; SUMMIT POR TAPER SZ10 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR