MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary : no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Date j&j became aware: 09/04/2018.Name of reporter: mr (b)(6).Hospital name: (b)(6).Product name: pinnacle liner.Did the event happen during a procedure? no.Was the product being used in a clinical trial? not that i am aware of event outcome/how was it managed? reported to me.I am not trying to get him some instruments to help stop the reoccurring.Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? no, potentially in the future.Has the reporter facility indicated there may be legal action? no.Is the product available for return? no, there is no revision case.Please give a detailed explanation of the event: surgeon reported that he suspects fracture of ceramic liners.After doing routine checks of xrays he noticed what looks like fragments on 4 (out of over 160 total cases).He has no idea if this is a ceramic fracture and no patients have reported symptoms.He will update us if anything progresses or if any more information comes out.I have discussed ceramic insertion surgical technique with him and the potential to get some insertion instruments just in case this can help.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7804927
• MDR Text Key: 118106753
• Report Number: 1818910-2018-67379
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1