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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US 1818910 PINN SECTOR W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
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.
 
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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 Key7669787
MDR Text Key113419157
Report Number1818910-2018-63922
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295010302
UDI-Public10603295010302
Combination Product (y/n)N
PMA/PMN Number
K071784
Number of Events Reported1
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 Number1217-32-052
Device Catalogue Number121732052
Device Lot NumberHR0937
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Initial Date Manufacturer Received 06/13/2018
Initial Date FDA Received07/09/2018
Supplement Dates Manufacturer Received07/10/2018
12/10/2019
05/20/2021
Supplement Dates FDA Received08/03/2018
12/10/2019
06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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