MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 EA DELTA CER INSERT 36IDX52OD; HIP ACETABULAR LINERS

Catalog Number 121881752

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2018

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

I would like to report a smashed ceramic liner, the revision surgery took place today at (b)(6) hospital, surgeon ¿ mr (b)(6).

Manufacturer Narrative

Product complaint #: (b)(4).This is a duplicate report of (b)(4).(b)(4) is being converted to a npi record as it is a report duplication.All new information pertaining to the event, all updates to investigation(s) and/or regulatory reporting will be maintained in (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.Product complaint # (b)(4).Investigation summary: (b)(4) have been reviewed and determined to be duplicate complaint records.(b)(4) is approved to be converted to an npi record.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7841467
• MDR Text Key: 119024775
• Report Number: 1818910-2018-68271
• Device Sequence Number: 1
• Product Code: KWY
• 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,Followup,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881752
• Device Lot Number: 8030318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention