MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Asr medical records received.After review of medical records the patient was revised to address left hip failed arthroplasty, metallosis, small area of inflammation and small tear about the abductors.The patient complaint of increasing pain and the mri showed an area of soft tissue disruption.Operative note indicated, there appeared some minor disruption along the posterion capsule.It was also indicated in the medical records that the patient has elevated metal ion levels.Doi: (b)(6) 2007.Dor: (b)(6) 2019.(left hip).

• Brand Name: SUMMIT POR TAPER SZ3 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: 10071323
• Report Number: 1818910-2020-12265
• Device Sequence Number: 17082003
• Product Code: JDI
• UDI-Device Identifier: 10603295060048
• UDI-Public: 10603295060048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 1570-11-090
• Device Catalogue Number: 157011090
• Device Lot Number: A6AEG1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/19/2020
• 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: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR