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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; METAL FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD METAL
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); Numbness (2415); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 12/14/2021
Event Type  Injury  
Event Description
A patient called requesting additional information regarding a second revision she had involving depuy synthes implants.She stated that "the second one was much worse with metallosis, footdrop, numbness and tingling.The second revision on december which is much worse, a result probably long lasting for the rest of my life the injury from the failure of your device." doi: (b)(6) 2019, dor: (b)(6) 2021, affected side: right hip.
 
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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : 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 lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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
Medical records received.(b)(6)2021 revision notes indicate the patient received a right total hip revision due to metallosis and a broken liner.Upon entering the joint, black fluid was encountered along with black tissue, and clear signs of metal debris were noted by the surgeon.The liner was noted to be worn, fractured, and disassociated in part from the cup.Head and liner revised to dual mobility construct.No noted complications.(b)(6)2021 post-op provider notes indicate the patient presented with significant 10/10 pain post revision and cramping in the right leg.The provider indicates it is likely swelling/irritation of the sciatic nerve or muscles in the hip/thigh resulting in foot weakness.Post-up protocols and iv pain meds were given.Provider states the patient began to improve by post-op day 2.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : 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 lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNK HIP FEMORAL HEAD METAL
Type of Device
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 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key15239893
MDR Text Key298036592
Report Number1818910-2022-15976
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 08/17/2022
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 FEMORAL HEAD METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/29/2022
Initial Date FDA Received08/17/2022
Supplement Dates Manufacturer Received08/25/2022
09/20/2022
10/26/2022
Supplement Dates FDA Received08/26/2022
10/06/2022
10/26/2022
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
UNK HIP ACETABULAR LINER POLY.; UNK HIP FEMORAL HEAD METAL.
Patient Outcome(s) Required Intervention;
Patient SexFemale
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