MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 15X20; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Anxiety (2328); Depression (2361); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	05/20/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
New ecm record created in order to update legacy complaint (b)(4).New etq record created in order to update etq (legal system) complaint number wpc (b)(4).Reason for original complaint ¿ patient seeking legal action.Update: 12/23/2012 - litigation received 11/30/2012.Litigation alleges patient had pain, permanent physical injuries and disfigurement after asr hip implant.There is no new information that would change the outcome of the investigation.Update rec'd 1/19/2016: supplemental info recieved.A dor was received.The taper sleeve is now being added to the complaint.This complaint was updated on: 1/29/2016 update 1/21/16 medical records received.Case information form and component stickers reviewed for mdr reportability.There is no new additional information that would affect the existing investigation.The complaint was updated on: feb 12, 2016 update ad 10 sep 2019.(b)(4) has been reopened under (b)(4) due to receipt of medical records.After review of medical records, the patient was revised to address metallosis, erosion and loss of the short external rotators.Operative findings include a darkly-hued, bulging bursa full of metal debris, absence of 50% of the inferior external rotators, dense adhesions and scarring.The s-rom stem was noted to be well-fixed and there was no evidence of infection.Doi:(b)(6) 2006 - dor: (b)(6) 2013, (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM STM STD 36+12L 15X20
• 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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16120756
• Report Number: 1818910-2023-00777
• Device Sequence Number: 18282158
• Product Code: JDI
• UDI-Device Identifier: 10603295178231
• UDI-Public: 10603295178231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2023

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: 56-3620
• Device Catalogue Number: 563620
• Device Lot Number: 2100551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2006
• 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 +3.; ASR ACETABULAR CUPS 58.; ASR UNI FEMORAL IMPL SIZE 51.; S-ROM*SLEEVE PRX ZTT, 20D-SML.; SROM STM STD 36+12L 15X20.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 138 KG