MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-12-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	06/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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, it was indicated that the patient complaints of right hip pain.The patient was then revised for failed metal-on-metal left total hip arthroplasty, elevated systemic metal ion levels, mri consistent with altr.Operative notes reported that there was blackened oily material and fluid found around more than 500ml.The abductor muscle were found in poor condition and detached from the anterior aspect of the greater trochanter.Further debridement of the entire effective joint space was carried out and all abnormal-appearing tissue, scar, and membranes were cleared.A number of heterotopic bone islands were identified in the abductor muscles.The significant volume of inflammatory blackened tissue was excised from the entire intracapsular and affected joint space.Radical debridement occurred in the posterior recesses and down into the ischium where there was a large osteolytic lesion.Operative finding reported that there was a severe metal reaction surrounding the joint.The entire proximal femur was osteolytic and the bone was absent surrounding the proximal portion of the stem.It was also mention that radical debridement of florid metal-on-metal reaction and metallic wear debris, impaction grafting of proximal femoral bone defects was seen on the patient, pelvic bone grafting, and abductor muscle repair.Doi: (b)(6) 2005; dor: (b)(6) 2016; left hip.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ5 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: 9831828
• Report Number: 1818910-2020-07877
• Device Sequence Number: 2830202
• Product Code: LPH
• UDI-Device Identifier: 10603295060161
• UDI-Public: 10603295060161
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 1570-12-110
• Device Catalogue Number: 157012110
• Device Lot Number: ZC9EW1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR