MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-01-080
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Test Result (2695); No Code Available (3191)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the surgeon replaced metal liner with poly liner and ts ceramic head due to elevated ion levels.Bilateral metal-on-metal hip patient was asymptomatic prior to falling and fracturing left hip in inter-trochanteric area.The surgeon had planned to place a cable around the inter-trochanteric region of the left femur but ultimately decided that it wasn't necessary.Implants remaining in patient: summit porous size 2 std; 50mm pinnacle sector cup; 35mm x 6.5mm acetabular screw.Doi: (b)(6) 2005; 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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate no code available (3191) is used to capture fall, blood heavy metal increased and surgical intervention.
Event or Problem Description
After a review of the medical records, the patient was revised to address the left proximal fracture on the femur, osteolysis, metal ion toxicity, pseudotumor, and minimal taper wear on the femoral stem.Revision note indicated that there was a large amount of resolving hemarthrosis fluid that was found after t-capsulotomy was performed.The head has minimal taper wear and small localized osteolytic on the cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.H10 additional narrative: added: b1.

• Brand Name: SUMMIT POR TAPER SZ2 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: 9336858
• Report Number: 1818910-2019-116711
• Device Sequence Number: 1873458
• Product Code: JDI
• UDI-Device Identifier: 10603295059332
• UDI-Public: 10603295059332
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/22/2019

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: 1570-01-080
• Device Catalogue Number: 157001080
• Device Lot Number: Y2FEL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/05/2019; 06/16/2020; 07/07/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/11/2019; 07/01/2020; 07/08/2020
• 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; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M 28MM 8.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE BONE SCREW 15 MM; PINNACLE BONE SCREW 15 MM; PINNACLE MTL INS NEUT28IDX50OD; PINNACLE SECTOR II CUP 50MM; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 64