MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 28MM +1.5; HIP CERAMIC FEMORAL HEADS

Catalog Number 136528310

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

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.

Event Description

During the surgery, even though the ceramic femoral head was assembled to femoral stem.It was reported that during the application, they couldn't fit the head to the stem.It was said that there can be a problem between con and head.Head liner dislocation didn't happen.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: examination of the returned device(s) confirms the reported event.Product problem has not been identified.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.Device history lot : 7831898.Device history review : product code 136528310, work order 7831898 was manufactured on 08-jan-2014.(b)(4) parts were manufactured per specification and all raw materials met specification.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: DELTA CER HEAD 12/14 28MM +1.5
• Type of Device: HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7199008
• MDR Text Key: 97491782
• Report Number: 1818910-2018-51416
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033271
• UDI-Public: 10603295033271
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K011533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136528310
• Device Lot Number: 7831898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2014
• 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
• Patient Age: 63 YR
• Patient Weight: 58