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

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 07/31/2020

Event Type  Injury  

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 Description

The patient was revised to address stem and sleeve subsided approximately 1 cm.Explanted acetabular liner, femoral head, srom sleeve and srom stem.Doi: (b)(6) 2019, dor: (b)(6) 2020, right side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10403451
• MDR Text Key: 202804333
• Report Number: 1818910-2020-18094
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295170648
• UDI-Public: 10603295170648
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 52-1485
• Device Catalogue Number: 521485
• Device Lot Number: 9054587
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 36IDX54OD; DELTA CER HEAD 11/13 36MM +9; SROM*STM ST,36+8L NK,18X13X160; ALTRX +4 10D 36IDX54OD; DELTA CER HEAD 11/13 36MM +9; SROM*STM ST,36+8L NK,18X13X160
• Patient Outcome(s): Required Intervention