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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Test Result (2695); No Code Available (3191)
Date of Event	03/16/2020
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 revised metal liner and head ball in right hip due to elevated ion levels.This patient has bilateral metal on metal hips.The left hip was implanted on (b)(6) 2005 and revised to poly liner and ts ceramic head on (b)(6) 2019.The patient is minimally symptomatic and full weight bearing.Patient has summit hip stem and pinnacle 54mm sector cup which remained in patient.Hip stem size unknown.Lot numbers on implants remaining in patient unknown.Regarding the two screws removed from the cup, i estimated their length, 25mm and 35mm because the implant data was not available.Doi: (b)(6) 2019.Dor: (b)(6) 2020; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a duplicate report of 1818910-2019-117905.1818910-2020-10214 is being retracted as it is report duplication.1818910-2019-117905 will be kept for investigation purposes¿.

• 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: 9924612
• Report Number: 1818910-2020-10214
• Device Sequence Number: 3296690
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 1570-01-080
• Device Catalogue Number: 157001080
• Device Lot Number: Y2FEL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT POR TAPER SZ2 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 65