MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 PINN SECTOR W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-052

Device Problems Product Quality Problem (1506); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 06/13/2018

Event Type  malfunction  

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

It was reported that the handle stuck to cup.They had to use new cup and different handle.Surgical delay of 3 minutes.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> examination of the returned device was unable to confirm the complaint.Depuy considers the investigation closed at this time.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

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device was unable to confirm the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Territory 228 reported that the handle stuck to cup.Examination of the device was unable to confirm the complaint.A functional check with a mating impactor found the device to function as intended.The root cause appears to be undetermined with no product problem identified.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Based on the investigation, the need for corrective action is not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Continue to monitor complaints under post market surveillance (b)(4).Device history lot: examination of the device was unable to confirm the complaint.Mre not performed.

• Brand Name: PINN SECTOR W/GRIPTION 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7669787
• MDR Text Key: 113419157
• Report Number: 1818910-2018-63922
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010302
• UDI-Public: 10603295010302
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2018

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 Model Number: 1217-32-052
• Device Catalogue Number: 121732052
• Device Lot Number: HR0937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 07/10/2018; 12/10/2019; 05/20/2021
• Supplement Dates FDA Received: 08/03/2018; 12/10/2019; 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1