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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ELITE PLUS OGEE CUP 28/47; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US ELITE PLUS OGEE CUP 28/47; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS Back to Search Results
Model Number 9653-28-047
Device Problems Loss of or Failure to Bond (1068); Naturally Worn (2988)
Patient Problems Joint Laxity (4526); Physical Asymmetry (4573)
Event Date 02/16/2023
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
Revised a thr of c-stem and marathon cemented cup from approximately 20 years ago.Original surgeon was dr and the operation was at qeii jubilee hospital.Primary reason for revision was for instability/loosening of the cup.Once the pt was open and dislocated the surgeon removed the head from the stem.28mm metal head +3 with 9/10 taper, the head appeared to have minimal wear.Due to limited space and access to the acetabulum the surgeon decided to remove the stem.Once removed the stem appeared to have minimal wear with nil signs of damage.Size 3 std.The cement mantle for the stem remained in tack and was happy to keep it for new amt c-stem.The surgeon then removed the marathon cemented cup.Cup removed with cement attached to cup, with minimal obvious wear.Unsure of cup size as not visible on rim.Surgeon then implanted a hybrid zimmer acetabular cup and liner.The surgeon downsized the stem for new cement mantle and adjustment of version of the stem.Size 2 ho c-stem amt.Ceramic 36mm +1.5mm head implanted.Good stability and improved leg length discrepancy.
 
Event Description
Additional information received indicated that the cement used was not a depuy cement.Primary reason for revision was for instability/loosening of the cup.The surgeon then removed the marathon cemented cup.Cup removed with cement attached to cup, with minimal obvious wear.Affected side was the left 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.
 
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 : the device associated with this report was not returned to depuy synthes for evaluation.Photo evidence provided was reviewed and found extraction damage and tissue adhered, however no visible evidence of a device nonconformance was found during the investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.
 
Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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 records evaluation (mre) was not performed as no lot number was provided for this device.
 
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Brand Name
ELITE PLUS OGEE CUP 28/47
Type of Device
MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS
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 Key16477253
MDR Text Key310590764
Report Number1818910-2023-04920
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295318835
UDI-Public10603295318835
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K871867
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,Followup,Followup,Followup
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9653-28-047
Device Catalogue Number965328047
Device Lot NumberXVC-67
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2001
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
C-STEM CENTRALIZER; C-STEM PMMA END CAP; C-STEM SZ3; CEMENT RESTRICTOR SIZE 3; ELITE MODULAR HD 28MM +3; UNK HIP ACETABULAR CUP; UNK HIP FEMORAL HEAD METAL C-STEM; UNK HIP FEMORAL STEM C-STEM; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT (COMPETITOR PRODUCT, UNK MFG); UNKNOWN BONE CEMENT (COMPETITOR PRODUCT, UNK MFG); UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP ACETABULAR LINERS
Patient Outcome(s) Required Intervention;
Patient SexMale
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