MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 48MM METAL ON METAL SHELL; S-ROM HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 859834

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 10/29/2019

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

It was reported that the patient had a right total hip replacement approximately 18 years ago.It was with a srom stem and ultima metal on metal cup.Patient was experiencing pain and discomfort and was brought in for revision.The cup was loose at bone to implant interface.A new competitor cup was implanted along with a new ceramic head in the existing srom stem.Doi: (b)(6).Dor: (b)(6) 2019.Right hip.With 1 hour surgical delay.

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 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: 48MM METAL ON METAL SHELL
• Type of Device: S-ROM HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9372251
• MDR Text Key: 183271375
• Report Number: 1818910-2019-117952
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 859834
• Device Lot Number: 477172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR