MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM STM STD 36+12L 13X18; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 563618

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

Reason for revision: loosening.No delay in the surgery.No ae reported.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: SROM STM STD 36+12L 13X18
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 10302428
• MDR Text Key: 199719916
• Report Number: 1818910-2020-16396
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P040023
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 563618
• Device Lot Number: 8269099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +3; PINNACLE 100 HA ACET CUP 54MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR