MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	52-1485
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Der states asr revision, originally implanted by the surgeon.Cobalt level of 4.4, chromium level of 4.7.Srom stem stayed implanted.Revised cup to a competitive cup, replaced srom head.No further patient information available.Doi: (b)(6) 2008; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the complaint investigation concluded that the event was related to the asr platform which was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.This stem is not part of the asr family however it did form part of the joint construct.There was no allegation of deficiency with this device.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10022287
• Report Number: 1818910-2020-11657
• Device Sequence Number: 2714646
• Product Code: LPH
• UDI-Device Identifier: 10603295170648
• UDI-Public: 10603295170648
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: 06/30/2012
• Device Model Number: 52-1485
• Device Catalogue Number: 521485
• Device Lot Number: 2417738
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 07/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR