MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	08/27/2020
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
Clinical adverse event received for soft tissue infection with possible deep infection event is serious and is considered moderate event is possibly related to both device and procedure.Date of implantation: (b)(6) 2014.Date of event (onset): (b)(6) 2020 (right hip).Treatment: none (awaiting surgical i&d with possible revision).
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.In reviewing provided patient x-ray images it was not possible to confirm the reported infection or a root cause.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.
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.
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.No code available (3191) is used to capture device revision or replacement and not surgical intervention.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10559982
• Report Number: 1818910-2020-20523
• Device Sequence Number: 1218534
• Product Code: JDI
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/01/2020

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: 52-3420
• Device Catalogue Number: 523420
• Device Lot Number: 3601100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/08/2020; 10/15/2020; 10/19/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 09/28/2020; 10/16/2020; 10/23/2020
• 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: ALTRX +4 NEUT 36IDX56OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +3; PINNACLE 100 ACET CUP 56MM; S-ROM*SLEEVE PRX ZTT, 20F-SML; ALTRX +4 NEUT 36IDX56OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +3; PINNACLE 100 ACET CUP 56MM; S-ROM*SLEEVE PRX ZTT, 20F-SML
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 102