MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722050

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Joint Disorder (2373)

Event Date 08/08/2019

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

The primary surgery was performed on (b)(6) 2015 via tha.It was reported that there were suspected wear of the liner, breakage, or dissociation by x-ray of periodic examination.Also, it was confirmed that the patient had pain and there was a limited range of motion.Thus, the revision surgery was scheduled to be performed on (b)(6) 2019 by replacing the liner (p/n: 122428050), the cup (p/n: 121722050), the head (p/n: 152190059), the stem (p/n: 900534210) with the sleeve (p/n: 521483), the apex hole eliminator (p/n: 124603000).It was hard to consider that wear had occurred and progressed rapidly because there was no problem at all at the time of 3 months before the periodic examination, it was inferred that the cause was breakage or dissociation.No further information is available.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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).Investigation summary: the devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 will be filed as appropriate.

Manufacturer Narrative

Product complaint # :(b)(4).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. .

Event Description

Additional information received indicating that the revision surgery was performed on (b)(6) 2019 as scheduled by replacing the liner, the head.The cup was retained by dr¿s judgement.The liner had been slipped off and had been dissociated to inferior of the cup.The head and the cup were in direct contact with each other, it was slightly like a metallosis.Although there was no sign of wear of the liner on the sliding surface especially, the ard tab was missing 5/6 parts, and it seemed that the entirety was slightly distorted into an ellipse.The surgery was completed without problem, and it was unknown whether there was a surgical delay or not.

• Brand Name: PINNACLE SECTOR II CUP 50MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8885493
• MDR Text Key: 154117813
• Report Number: 1818910-2019-100849
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009818
• UDI-Public: 10603295009818
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 07/22/2019

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: 121722050
• Device Lot Number: 8058321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 08/14/2019; 10/14/2019
• Supplement Dates FDA Received: 08/21/2019; 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR