MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SELF CENT HIP 48X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103548000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Not Applicable (3189)

Event Date 06/24/2018

Event Type  malfunction  

Manufacturer Narrative

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 when inserting the bipolar head, the surgeon said it made an unusual sound and felt loose.Said it didn¿t feel normal and was concerned about the integrity of the implant.A new bipolar head of the same size was opened and the surgeon said the new one felt better and he completed the surgery with no further issues.  doe: (b)(6) 2018.

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

(b)(4).Examination of the returned product is unable to identify a product problem.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.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SELF CENT HIP 48X28 BRN
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7695866
• MDR Text Key: 114313790
• Report Number: 1818910-2018-64634
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003380
• UDI-Public: 10603295003380
• Combination Product (y/n): N
• PMA/PMN Number: K182672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2018

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: 103548000
• Device Lot Number: HT2367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Manufacturer Received: 06/24/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 07/18/2018; 12/04/2018
• Supplement Dates FDA Received: 08/06/2018; 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR