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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121881752
Device Problems Fracture (1260); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 05/22/2023
Event Type  Injury  
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.
 
Event Description
Liner breakage post-op.More than 9 months after bilateral hip arthroplasty, the patient had left hip movement sound.The patient went to the hospital for examination, and it was found by x-ray that the ceramic liner implanted on the left side was cracked.A second surgery was required, but the timing of the second surgery is currently uncertain.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence confirm the reported allegation.The ceramic insert was found fractured into multiple fragments.Additionally, signs of metal transfer can be observed on the inner surface and on the fractured fragments, most likely caused by chafing between metal parts and the fragments of insert.Based on the observations, it reasonable to conclude that audible sound would be present.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the ceramic insert belongs to the shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.Device history review a manufacturing record evaluation was performed for the finished device [121881752 / 3719590] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
 
Event Description
Additional information was received and stated that the patient underwent a second procedure on (b)(6) 2023.The fractured liner and worn hip femoral head were removed.Replaced with new ceramic head and acetabular liners.
 
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Brand Name
EA DELTA CER INSERT 36IDX52OD
Type of Device
PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI  
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key17099407
MDR Text Key316932952
Report Number1818910-2023-12009
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 06/09/2023
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 Number121881752
Device Lot Number3719590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2023
Initial Date FDA Received06/09/2023
Supplement Dates Manufacturer Received06/29/2023
Supplement Dates FDA Received06/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2022
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
UNKNOWN HIP FEMORAL HEAD.
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient SexMale
Patient Weight71 KG
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