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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL; METAL ACETABULAR LINER
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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL; METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER METAL
Device Problems Difficult to Remove (1528); Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Date 07/08/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter 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
Mom pinnacle litigation record received.Patient alleges elevated metal ion, suffered injury to his muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity, suffered injuries, pain, metallosis, metal wear, loss of enjoyment of life, limitation of daily activities, physical disability, experienced emotional trauma and distress, mental anguish, and economic loss, permanent instability and loss of balance, immobility, and suffering.Doi: (b)(6) 2010, dor: (b)(6) 2021, (unknown 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.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
 
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.H10 additional narrative: added: a2 (dob), b5 and d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.
 
Event Description
Medical records received.On (b)(6)2021, patient was revised due to failed right total hip arthroplasty due to corrosion and metal-on-metal articulation.Surgical notes indicated patient having increasing pain and worked up for potential corrosion of nature of implant placed.Patient indeed have an elevated cobalt level.Affected side: 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.Device history lot a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
 
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 report corrosion, pseudotumor, altr, and synovitis.
 
Event Description
Medical records received.Dor (b)(6) 2021: male patient received a right hip mom revision to treat pain, walking difficulty, and elevated metal ions secondary to adverse local tissue reaction (altr).Upon entering the joint, a pseudotumor, synovitis, and large effusion were debrided.Altr was confirmed.The cup was well-fixed but revised as the surgeon was unable to disassemble the metal liner from the cup.The head and liner had signs of wear.There was noted corrosion on the head/neck junction of the femoral components.The stem was well-fixed, and the taper was cleaned and retained.The patient received a competitor mdm cup/liner paired with a ceramic depuy head.The procedure was completed without complications.
 
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.
 
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Brand Name
UNK HIP ACETABULAR LINER METAL
Type of Device
METAL ACETABULAR LINER
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 Key14874335
MDR Text Key295036032
Report Number1818910-2022-12054
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
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 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/21/2023
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
UNK HIP BONE SCREW.; UNK HIP FEMORAL HEAD METAL.; UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP FEMORAL STEM.
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient SexMale
Patient Weight86 KG
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