MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DUR OPT CER INS 32/52; DURALOC OPTION IMPLANTS : HIP CERAMIC ACETABULAR LINERS

Catalog Number 159964052

Device Problem Fracture (1260)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 11/29/2018

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.(b)(4).

Event Description

The patient was revised to address broken ceramic liner.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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: DUR OPT CER INS 32/52
• Type of Device: DURALOC OPTION IMPLANTS : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS118 DT; UK LS118DT
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8200170
• MDR Text Key: 131524919
• Report Number: 1818910-2018-79226
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 159964052
• Device Lot Number: 1893663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR