MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,30 NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	52-3293
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the patient was having some pain in their hip.Thought the head was wearing through the poly.Upon examination, the head was wearing on the side of the poly.The s rom 18x13x160 30 std stem was removed and version was changed in the stem.Surgeon would like to have poly examined to see if any manufactures issues.Doi: (b)(6) 2017, dor: (b)(6) 2020, affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10314665
• Report Number: 1818910-2020-16691
• Device Sequence Number: 11031418
• Product Code: JDI
• UDI-Device Identifier: 10603295170983
• UDI-Public: 10603295170983
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 52-3293
• Device Catalogue Number: 523293
• Device Lot Number: 3601098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 36IDX58OD; S-ROM M HEAD 36MM -3; S-ROM*STM STD,30 NK,18X13X160; ALTRX NEUT 36IDX58OD; S-ROM M HEAD 36MM -3; S-ROM*STM STD,30 NK,18X13X160
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR