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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 121936152
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 04/15/2024
Event Type  Injury  
Event Description
Patient operated primary at hospital on (b)(6) 2019.Suddenly in (b)(6) 2024 the patient felt a difference in the hip and heard noise.Hospital did a revision of the cup/liner on (b)(6) 2024.Surgeon took out the cup and inserted another cup, not from depuy synthes.Doi: (b)(6) 2019.Doe: (b)(6) 2024.Affected side: right.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: description of complaint (please supply specific details): patient operated primary at (name removed) hospital on (b)(6) 2019.Suddenly in (b)(6) 2024 the patient felt a difference in the hip and heard noise.Hospital did a revision of the cup/liner on (b)(6) 2024.Surgeon took out the cup and inserted another cup, not from depuy synthes.The product was not returned to depuy synthes, however photos were provided for review.See attachment "gentofte, x-ray broken marathon liner, 150424.Pdf" the x-ray investigation revealed that cup presented a disassociation with the liner, it is unknown the exact root cause, however based in the information provided it is reasonable to expect a fracture on the liner, possible on one or more ard.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 36idx52od] would contribute to the complained device issue.  based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information was received: a.Can you please confirm if any depuy head was revised or used in patient? as can be seen from the x-ray, pt depuy corail had a prosthesis with an associated metal head.At our reoperation, this was replaced with a new depuy corail head on the existing corail prosthesis.B.Please provide the product details of head? depuy corail head (which i remember sent together with the damaged liner and cup).Size cannot be specified from here.C.Please specify the patient symptoms? as previously written, well-functioning hip, until 2024, when a mechanical scraping sensation is felt in the hip.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
 
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Brand Name
PINN MAR +4 10D 36IDX52OD
Type of Device
PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key19179931
MDR Text Key341010688
Report Number1818910-2024-09051
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295014577
UDI-Public10603295014577
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K033273
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/25/2024
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 Number121936152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/15/2024
Initial Date FDA Received04/25/2024
Supplement Dates Manufacturer Received05/06/2024
05/07/2024
Supplement Dates FDA Received05/06/2024
05/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PINNACLE SECTOR II CUP 52MM; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient SexFemale
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