MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 13X18; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3618
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
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
Left tha completed due to osteoarthritis.A depuy asr head, asr cup, and taper sleeve adapter were used.Patient completed of audible noise and popping in the hip.Revision completed secondary to adverse metal-on-metal reactions and cobalt chromium toxicity.Patient had moderate alval limited to the capsule with small amounts of tissue necrosis around the capsule.Doi: (b)(6) 2007; dor: (b)(6) 2020; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Mfr# 1818910-2022-00389, is being retracted since it was found to be a duplicate of 1818910-2021-07167.Mfr# 1818910-2021-07167 will be kept for investigation purposes.
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 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.Mfr# 1818910-2022-00389 is being retracted since it was found to be a duplicate of 1818910-2021-07167.Mfr# 1818910-2021-07167 will be kept for investigation purposes.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SROM STM STD 36+12L 13X18
• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13190907
• Report Number: 1818910-2022-00389
• Device Sequence Number: 17222215
• Product Code: JDI
• UDI-Device Identifier: 10603295178224
• UDI-Public: 10603295178224
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• 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): 01/06/2022

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: 56-3618
• Device Catalogue Number: 563618
• Device Lot Number: 2442241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 02/01/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/15/2022; 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADAPTER SLEEVE 11/13 +0; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; S-ROM*SLEEVE PRX ZTT, 18D-LRG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male