MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-100
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2020
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
Asr claim received.After review of medical record, patient was revised to address right hip metallosis with soft tissue reaction.Patient experienced pain and discomfort and elevated metal ion.Operative findings stated that there was significant corrosion at the head and neck junction of femoral stem.There were sign of pseudotumor.Revision notes stated that synovial fluid was obtain for culture.Doi: (b)(6) 2007; 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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ4 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: 12009003
• Report Number: 1818910-2021-12768
• Device Sequence Number: 3425956
• Product Code: LPH
• UDI-Device Identifier: 10603295060055
• UDI-Public: 10603295060055
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K001991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• 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): 01/24/2020

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: 1570-11-100
• Device Catalogue Number: 157011100
• Device Lot Number: BW6AD1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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 54; ASR UNI FEMORAL IMPL SIZE 47; SUMMIT POR TAPER SZ4 HI OFF; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; SUMMIT POR TAPER SZ4 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR