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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Tissue Injury (4559)
Event Date 05/25/2021
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
It was reported that the patient presented with a soft tissue psuedo tumor in lateral upper thigh.Otherwise the total hip prosthesis was stable and patient had no complaints of function.The surgeon removed the tumor.Inserted the following 36/52 polyethylene liner.+4 / 10 deg, 36 / 8.5.Head.Ceramic.Doi: unknown - dor: (b)(6) 2021 (unknown side).
 
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 : per wi-3430, it has been determined that should additional reports be identified for the alleged adverse symptoms and the product code reported, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.
 
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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
MDR Report Key11968194
MDR Text Key255179458
Report Number1818910-2021-12237
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 company representative,health
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
Was Device Available for Evaluation? No
Date Manufacturer Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR HOLE ELIMINATOR; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL STEM SUMMIT; UNKNOWN HIP FEMORAL HEAD; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR HOLE ELIMINATOR; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL STEM SUMMIT; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient Age73 YR
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