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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; HIP IMPLANT : METAL FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; HIP IMPLANT : METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD METAL
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Event Date 02/22/2023
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
Pinnacle metal on metal medical records received.After review of the medial records there was no information provided pertaining to patient harm and device related problem.No revision records received yet.Doi: oct 30, 2007, dor: feb 22, 2023, right 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.
 
Event Description
After a review of medical records patient was revised due to metal-on-metal hip failure.Operative notes indicated there was sort of typical brown almost sawdust-type material present in the hip joint.There were some corrosion products on the trunnion itself and these were cleaned off.
 
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.
 
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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
 
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Brand Name
UNK HIP FEMORAL HEAD METAL
Type of Device
HIP IMPLANT : METAL FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key16777437
MDR Text Key313661660
Report Number1818910-2023-08314
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/20/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/14/2023
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
APEX HOLE ELIM POSITIVE STOP.; ARTICULES, M-SPEC FEMORAL HEAD, 44 MM + 1.5 OFFSET.; DEPUY PINNACLE 100 ACETABULAR CUP SIZE 62 MM.; HOLE ELIMINATOR.; PINNACLE 100 ACET CUP 62MM.; PINNACLE MTL INS NEUT44IDX62OD.; SUMMIT DUOFIX TAP SZ7 HI OFF.; UNK HIP FEMORAL STEM SUMMIT.
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient SexMale
Patient Weight90 KG
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