MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ3 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-02-090
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/30/2020
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
Unf and medical records received.After review of medical records patient was revised to addressed adverse reaction to metallic debris(armd), pain, systemic symptoms of cognitive decline and pseudotumor.The stem was in 15 degrees anteversion and the trunnion and head showed gross corrosion.The acetabular component was in 45 degrees abduction and anteverted about 20 degrees and had minor lysis.Mri findings reported of significant metal artifact is present for the left hip prosthesis.Doi: (b)(6) 2008 : 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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Event or Problem Description
Prior to revision patient alleges stiffness, injury, instability, weakness and metallosis.During revision doctor found out inflamed hypertrophic synovium and anterior capsule was thickened.Doi: (b)(6) 2008 dor: (b)(6) 2020 left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Appropriate term / code not available (e2402) is used to capture injury (e20), if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ3 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: 11613153
• Report Number: 1818910-2021-06934
• Device Sequence Number: 3159768
• Product Code: LPH
• UDI-Device Identifier: 10603295059448
• UDI-Public: 10603295059448
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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,Followup
• Report Date (Section B): 03/18/2021

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: 1570-02-090
• Device Catalogue Number: 157002090
• Device Lot Number: B58DG1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 04/28/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/22/2021; 04/28/2021
• 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: ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT DUOFIX TAP SZ3 STD OFF; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT DUOFIX TAP SZ3 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR