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

Model Number	1570-12-100
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Medical record received.After review of medical record, patient was revised to address metallosis with pain.Revision notes stated that the femoral head was removed from the trunnion.There was noted to be some trunnionosis with blackened staining at the trunnion.The liner was removed.The remaining metalosis was removed.Surgical pathology report stated that fragments of skeletal muscle, fibroadipose tissue, and mildly reactive synovium with mild chronic predominantly histiocytic inflammation, mild hemosiderosis and metallosis and rare foreign body giant cell reaction around refractile weekly birefringent particles.Left hip bone and tissue consist of multiple pink tan soft tissue fragments measuring 7.2x6.4x1.1cm in aggregate.No acute inflammation diagnostic of infection seen.Doi: (b)(6) 2009 - dor: (b)(6) 2019 (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 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: 11736654
• Report Number: 1818910-2021-08963
• Device Sequence Number: 3832673
• Product Code: LPH
• UDI-Device Identifier: 10603295060154
• UDI-Public: 10603295060154
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• 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): 04/14/2021

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: 1570-12-100
• Device Catalogue Number: 157012100
• Device Lot Number: DK5BS1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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 -2.; PINN CAN BONE SCREW 6.5MMX20MM.; PINNACLE MTL INS NEUT36IDX50OD.; PINNACLE SECTOR II CUP 50MM.; ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 75