MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 APEX HOLE ELIM POSITIVE STOP; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Catalog Number 124603000

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2013

Event Type  malfunction  

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

Complaint description from etq: 1217-11-058 x1 pinnacle acetabular shell 100 series (lot: 311131) was implanted as per surgical technique.Subsequently, surgeon attempted to screw in (1246-03-000) apex hole eliminator (lot: d13033399) into acetabular shell.However, the apex hole eliminator could not screw into threads of acetabular shell.Therefore, a second apex hole eliminator (lot: d13050493) was opened.This too could not be implanted.The surgeon then said, although he had never had this issue in his multiple prior cases, the threads of the acetabular shell must have been burred.The surgeon decided to not worry about using a hole eliminator and subsequently implanted a shell liner, as per surgical technique.The operation was completed with no further problems.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the hole eliminator; with reported lot code d13033399, was not received for examination.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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 will be filed as appropriate.

• Brand Name: APEX HOLE ELIM POSITIVE STOP
• Type of Device: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8746150
• MDR Text Key: 174985486
• Report Number: 1818910-2019-97195
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: 10603295019688
• Combination Product (y/n): N
• PMA/PMN Number: K963309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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: 124603000
• Device Lot Number: D13033399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1