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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Unspecified Tissue Injury (4559)
Event Date 03/04/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
"literature article entitled "a minimum of 15-year results of cementless total hip arthroplasty using a 28-mm metal-on-metal articulation" written by chan-woo park, md, joo-hwan kim, md, seung-jae lim, md, young-wan moon, md, youn-soo park, md published by the journal of arthroplasty published online/accepted by publisher 4 mar 2020 was reviewed.The purpose of this study was to evaluate the clinical and radiographic outcomes of the previously reported cohort at a minimum follow-up of 15 years.The original cohort consisted of 171 primary thas (167 patients) using a 28-mm mom articulation performed between april 2000 and march 2002.Of these, 130 hips (126 patients) were reviewed at an average follow-up of 17.1 (range, 15-18) years.Clinical score, complications, presence of osteolytic lesion, serum metal ion concentrations, and implant survivorships were evaluated.X-ray images can be found on page 3 of article.It is noted 25 deaths occurred that were initially involved in the study, however, there is no indication or allegation a depuy product was the cause or contributed to any of the indicated deaths.The reason for the deaths is not indicated in the study.Depuy products: ultima cementless cup, s-rom cementless stem, unnamed metal-on-metal head and liner, and s-rom sleeve.There is no indication of any revision involving the s-rom sleeve.Adverse events: 9 patients are identified by age and gender.8 of the 9 underwent revision operations.The ninth patient has not undergone a revision operation.Case 1: male.26 years old.Revision to address infection and edema.Within one year post-primary.Cup, liner, head, and stem revised.Case 2: female.63 years old.Revision to address dislocation, groin pain, osteolysis, necrosis, and alval.Cup, liner, and head revised.Case 3: male.58 years old.Revision due to joint infection and edema.Cup, liner, head, and stem revised 2+ years after primary.Case 4: female.44 years old.Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval.Cup, liner, and head revised.Case 5: female.59 years old.Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval.Cup, liner, and head revised.Case 6: male.58 years old.Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval.Cup, liner, and head revised.Case 7: female.56 years old.Revision due to groin pain, osteolysis, elevated metal levels, and alval.Cup, liner, and head revised.Case 8: male.67 years old.Revision due to aseptic stem loosening and necrosis.Stem and head revised.Case 9: male.40 years old.X-ray imaging revealed osteolysis.No revision.".
 
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 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.
 
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Brand Name
UNKNOWN HIP ACETABULAR LINERS
Type of Device
HIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11109376
MDR Text Key233128822
Report Number1818910-2021-00009
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 12/18/2020
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? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/18/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received03/17/2021
Supplement Dates FDA Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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