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 Not Applicable (3189)

Event Date 08/22/2019

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

It was reported that the hole eliminator went through the sector cup.The surgeon could not get it back through the cup.It was somewhat threaded but would not become tight.They will try and retrieve post op xrays and send in later.Doi: unknown.Dor: (b)(6) 2019.Unknown affected side.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : d19050641.Device history batch : null.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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: 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: 9072328
• MDR Text Key: 185743262
• Report Number: 1818910-2019-104738
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

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: D19050641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1