MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121732056

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 04/06/2020

Event Type  Injury  

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

Hospital informed me of a usage re-supply request for an operation completed on (b)(6)2020 where by patient underwent a revision of a right acetabular liner and femoral head for a liner dissociation.Surgeon informed that patient reported hearing a crack while snowboarding followed by audible squeaking when walking and surgeon reported that follow up imaging shows femoral head articulating with acetabular shell.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrective action was not indicated.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN SECTOR W/GRIPTION 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10088166
• MDR Text Key: 192039638
• Report Number: 1818910-2020-12553
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121732056
• Device Lot Number: HG8758
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/11/2020; 06/23/2020
• Supplement Dates FDA Received: 06/01/2020; 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 36MM +5; DELTA CER HEAD 12/14 36MM +5; PINN MAR NEUT 36IDX56OD; PINN MAR NEUT 36IDX56OD; SUMMIT DUOFIX TAP SZ6 HI OFF; UNKNOWN HIP ACETABULAR CUP; DELTA CER HEAD 12/14 36MM +5; PINN MAR NEUT 36IDX56OD; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR