MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 18D-LRG; S-ROM ZTT

Model Number	55-0524
Medical Device Problem Codes	Corroded (1131); Naturally Worn (2988)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Test Result (2695); No Code Available (3191)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
Litigation alleges patient had pain, popping, ratcheting and grinding in and around hip and elevated metal ion levels after asr hip implant.Asr litigation record.Motion to re-open case and amended litigation received.Litigation alleges pain, popping, ratcheting and grinding in and around her right hip, elevated metal ion levels and emotional distress.It was reported that, during revision there was a large amount of brownish red clear fluid within the joint with a string sign of approximately 1-1/2 inches, consistent with a pseudotumor fluid accumulation.Doi: (b)(6) 2007.Dor: (b)(6) 2017, (right hip).

• Common Device Name: S-ROM ZTT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9756996
• Report Number: 1818910-2020-06044
• Device Sequence Number: 1865870
• Product Code: LPH
• UDI-Device Identifier: 10603295175292
• UDI-Public: 10603295175292
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2012

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2012
• Device Model Number: 55-0524
• Device Catalogue Number: 550524
• Device Lot Number: 2394497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/26/2020
• 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: 56 YR
• Patient Weight: 102