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

Model Number	1570-02-100
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Test Result (2695); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/24/2020
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
After review of medical records the patient was revised to address metallic wear and metallosis.Operative note reported synovium was bulging and had dark appearance this was incised and has a slightly opaque bright yellow fluid and some particulate whitish debris.Synovium led down had grayish appearance.There was slight corrosion at the taper however it was intact.Fibrous materiel dissected in the acetabulum.Metallic liner was noted to be disengage.Clinical visit prior to revision reported occasional locking up position and some pain due to possible metallic debris.Lab result shows elevated cobalt serum level and mri shows fluid accumulation right hip and the assessment metallosis.Doi: (b)(6) 2002; 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.
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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the injury.
Event or Problem Description
Litigation alleged that patient suffer from defects that cause excessive amount of cobalt and chromium to wear from the surface of the acetabular insert and from the femoral head, which causes the surrounding tissue and bone to die.Updated facility name and added associated contact.

• Brand Name: SUMMIT DUOFIX TAP SZ4 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: 10269101
• Report Number: 1818910-2020-15728
• Device Sequence Number: 19035445
• Product Code: LPH
• UDI-Device Identifier: 10603295059455
• UDI-Public: 10603295059455
• 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: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-02-100
• Device Catalogue Number: 157002100
• Device Lot Number: WE6K61002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/10/2020; 04/14/2021
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/11/2020; 04/26/2021
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT DUOFIX TAP SZ4 STD OFF; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT DUOFIX TAP SZ4 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 66