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

Model Number	1570-02-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	02/12/2020
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
Asr medical records received.After review of the medical records, the patient was revised to address pain and failed right hip arthroplasty.Operative note reported of black to gray appearance consistent with metallosis on the internal portion of the capsule.It was also indicated that the acetabular component itself was noticeably loose.The femoral component was well fixed with minimal metallic changes to the taper.Doi: (b)(6) 2010 dor: (b)(6) 2020, right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT DUOFIX TAP SZ5 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: 11784678
• Report Number: 1818910-2021-09727
• Device Sequence Number: 3854996
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2021

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 Expiration Date: 11/30/2019
• Device Model Number: 1570-02-110
• Device Catalogue Number: 157002110
• Device Lot Number: D57EF1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 06/08/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/06/2021; 06/08/2021
• 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: ADAPTER SLEEVES 12/14 +2; ASR 300 SPIKED CUP SIZE 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT DUOFIX TAP SZ5 STD OFF; ADAPTER SLEEVES 12/14 +2; ASR 300 SPIKED CUP SIZE 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT DUOFIX TAP SZ5 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR