MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM MARATHON LINER M 28 NEU; S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122070028

Device Problem Material Deformation (2976)

Patient Problem Tissue Damage (2104)

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.Initial reporter occupation: attorney.

Event Description

Ppf and medical records received.Ppf alleges loosening of cup, metal wear, and metallosis.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM MARATHON LINER M 28 NEU
• Type of Device: S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8549935
• MDR Text Key: 143072443
• Report Number: 1818910-2019-91589
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K924492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

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: 122070028
• Device Lot Number: V5VED1004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR