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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY Back to Search Results
Catalog Number UNK HIP ACETAB LINER POLY
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body Reaction (1868)
Event Date 02/07/2024
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.
 
Event Description
Patient was revised due to liner disassociation.Implant date is unknown as it was done elsewhere.A 52 mm cup was found to be well fixed and the head was a 36mm +1.5 metal head.It is unknown if the head is an articuleeze or an m spec head.Patient presents in clinic with grinding and squeaking in the left hip.Xrays show what appears to be a pinnacle shell and a reclaim hip stem but the femoral head is not centered in the cup leading surgeon to believe that there was a liner disassociation.Patient was scheduled promptly and brought to the operating room for a hip revision.Hip is dislocated and femoral head removed.Liner is found to be disassociated from cup and significant metallosis is present.An extensive dibridement is performed and there is mild wear in the superior posterior redion of the cup.The inner taper of the cup appears to be unaffected and a dual mobility liner is placed uneventfully and impacted.The metal liner is well fixed and a dual mobility liner and head are placed.No patient harm was noted and no delay took place.Doi: unknown.Dor: (b)(6), 2024.Affected side: left.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.
 
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Brand Name
UNK HIP ACETABULAR LINER POLY
Type of Device
ACETABULAR LINER
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
3035526892
MDR Report Key18717305
MDR Text Key335521520
Report Number1818910-2024-03449
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/15/2024
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 NumberUNK HIP ACETAB LINER POLY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2024
Initial Date FDA Received02/15/2024
Supplement Dates Manufacturer Received02/23/2024
Supplement Dates FDA Received02/26/2024
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 Unknown
Patient Sequence Number1
Treatment
UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient SexMale
Patient Weight120 KG
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