MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SROM STM STD 36+12L 15X20; HIP FEMORAL STEM

Model Number S-ROM TOTAL HIP SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Scar Tissue (2060); Anxiety (2328); Discomfort (2330); Depression (2361); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event 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 ¿ litigation alleges that the patient experienced pain and discomfort on account of his asr hip implant.Litigation further alleges that the patient exhibited symptoms of a loose implant.Update 10/3/2012 - plaintiffs preliminary disclosure form was received, which identified part/lot information, side and implant date.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update 12/23/2012 - additional litigation papers received 11/30/2012 and attached.There is no new information that would change the outcome of the investigation.Update rec'd 1/19/2016: supplemental info received.A dor was provided.The taper sleeve is 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 sticker sheets reviewed for mdr reportability.Revision surgery component sticker sheet noted a blood loss of 825ml.This will be added to patient harms.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 and metal debris.Metallosis was noted to be present on the trunnion as well.Added hospital, law firm, medical history, patient harms and product experience code.Corrected patient identifier.Doi: (b)(6) 2006 - dor: (b)(6) 2013.(right hip).

• Brand Name: SROM STM STD 36+12L 15X20
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16131081
• MDR Text Key: 307008039
• Report Number: 1818910-2023-00898
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295178231
• UDI-Public: 10603295178231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2023

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
• Device Model Number: S-ROM TOTAL HIP SYSTEM
• Device Catalogue Number: 563620
• Device Lot Number: 2190532
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +0.; ASR ACETABULAR CUPS 58.; ASR UNI FEMORAL IMPL SIZE 51.; S-ROM*SLEEVE PRX ZTT, 20D-SML; SROM STM STD 36+12L 15X20.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 138 KG