MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZT HA 18F-XXL; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 550153

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 09/11/2020

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

Patient with srom-pinnacle total hip replacement, had peri-prosthetic fracture, to below the distal tip of the stem.The srom femoral implant was removed.The cup and liner were examined and remained, insitu.Dr was advanced that depuy synthes would recommend changing the liner, but he declined as the patient was elderly and he did not want to extend the operative time any longer than required.A reclaim stem was implanted.

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.Device history lot: 2090285.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: d4 (lot), d11, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 10567865
• MDR Text Key: 207962648
• Report Number: 1818910-2020-20670
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K912713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 550153
• Device Lot Number: 2090285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 09/11/2020; 12/01/2020
• Supplement Dates FDA Received: 09/29/2020; 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +0; DELTA CER INSERT 36ID X 58OD; PINN SECTOR HA ACET CUP 58MM; SROM*STM ST,36+8L NK,18X13X160; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +0; PINN SECTOR HA ACET CUP 58MM; SROM STM ST,36+8L NK,18X13X160
• Patient Outcome(s): Required Intervention