MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 121932150

Device Problem Disassembly (1168)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/15/2018

Event Type  Injury  

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

Event: subluxated prosthesis, presenting noise when under movement (squeak?).Occurrence history: on (b)(6) 2017 mmam patient, at the (b)(6) hospital, patient underwent left hip arthroplasty surgery, however on (b)(6) 2018 the surgeon dr.(b)(6), reports that patient returned to the surgery with the subluxated prosthesis , presenting noise when under movement (squeak?).However, the patient has poly metal prosthesis.When performing rx (attachment), surgeon evaluated that the polyethylene insert may be loose, reason why it is causing the noise.Initial conduct based on the scientific articles (annex), will be to carry out revision of arthroplasty to exchange the components, in case the acetabulum is well positioned will only perform the exchange of the insert and femoral head.Surgeon would like to know if there have been other similar cases reported.Our concern is to justify to all clients immediately, since the subject has already spread in the group of hip surgeons, who are also our clients.Pinnacle sector acet cup 50 mm.Product code: 1217-22-050.Lot: 8393270.Pinn mar +4 10d 32idx50od.Product code: 121932150.Lot: c91787.Procedure: arthroplasty.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> no device associated with this report was received for examination.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.

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.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.Update: january 23, 2019.The acetabular liner has been received for examination.Examination of the liner does find evidence to support the reported disassociation event.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Product error regarding this report is not identified.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.Device history lot =null.Device history batch = null.Device history review =null.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: PINN MAR +4 10D 32IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7595550
• MDR Text Key: 110854111
• Report Number: 1818910-2018-61987
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014041
• UDI-Public: 10603295014041
• Combination Product (y/n): N
• PMA/PMN Number: K033273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121932150
• Device Lot Number: C91787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention