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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Corroded (1131); Degraded (1153)
Patient Problems Ossification (1428); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); No Code Available (3191); Physical Asymmetry (4573)
Event Date 01/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Occupation: lawyer.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 patient was having pain in their right hip.The surgeon determined the pain could be caused by the patient's mom implants.The metal liner and head were removed.Polyethylene liner and ceramic head were implanted.Doi: 2009, dor: (b)(6) 2019, right hip.
 
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.H10 additional narrative:  corrected: h6 (device).
 
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 device history record (mre) review, was not possible because the required lot code was not provided.
 
Event Description
In addition to what were previously reported, after review of the medical records, clinical visit reported moderate limp, walking difficulty, limited adl, synovial proliferation suggesting capsular dehiscence.X-ray reported to have heterotopic ossification to the prosthesis.Doi: (b)(6) 2009, dor: (b)(6) 2019, right hip 2nd revision.
 
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
Mri findings stated that there was some debris within the fluid collection.
 
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.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required part/lot number was not provided.Medical records reviewed (15 jun 2022) - from a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.See attached report.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.- without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications.- the device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not identified.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot a device history record (mre) review, was not possible because the required lot code was not provided.
 
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.Corrected : d10 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN HIP FEMORAL STEM
Type of Device
HIP FEMORAL STEM
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
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10246483
MDR Text Key198021666
Report Number1818910-2020-15284
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
12/14 ARTICUL 40MM M SPEC+1.5; 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN MULTIHOLE W/GRIPTION 58MM; PINN MULTIHOLE W/GRIPTION 58MM; PINNACLE MTL INS NEUT40IDX58OD; PINNACLE MTL INS NEUT40IDX58OD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP FEMORAL STEM; 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN MULTIHOLE W/GRIPTION 58MM; PINNACLE MTL INS NEUT40IDX58OD; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient SexMale
Patient Weight92 KG
Patient RaceWhite
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