MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*STM STD,30 NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523292
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event	09/20/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation: non-healthcare professional ¿ attorney (b)(4).
Event or Problem Description
Litigation papers allege the patient has significant discomfort, pain, stiffness, loss of motion, and, upon information and belief, loosening and/or dislocation of the hip, all of which results in difficult and painful mobility and ambulation, all of which is ongoing, and has or is at risk for metal toxicity from this implant, and needs ongoing care and treatment.It is further alleged the patient will have to undergo revision surgery.Ppf alleges elevated metal ions.Doi: (b)(6) 2011 - dor: (b)(6) 2011 (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot = > 3095763.Device history review = > a device history record (dhr) review was previously conducted on (b)(4).Review of the device history records did not reveal any related manufacturing deviations or anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8184129
• Report Number: 1818910-2018-78822
• Device Sequence Number: 16641003
• Product Code: JDI
• UDI-Device Identifier: 10603295170976
• UDI-Public: 10603295170976
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 03/10/2015
• Device Catalogue Number: 523292
• Device Lot Number: 3095763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 61