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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 Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104); Weakness (2145); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 07/23/2019
Event Type  Injury  
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. Initial reporter occupation: lawyer. (b)(4).
 
Event Description
Pinnacle medical records received. After review of medical records, the patient was revised due to wear of articulating bearing surface. Clinic visit reported of pain, trouble walking, discomfort, tenderness, inflammation, weakness and workup revealed abnormal soft tissue reaction around the hip. Operative note reported, there was scarring of the short external rotators of the posterior capsule. Dark stained synovial fluid tissue and fluid was noted and evidence of adverse local soft tissue reaction. The cup was well fixed and decided to retain it. There was extensive caseating material in the proximal femur and there was hypertrophic synovium, with dark staining of the tissues, as well as caseating material in the pubis and the ischium. Laboratory result for cobal and chromium were below 7 ppb. Doi: (b)(6) 2009; dor: (b)(6) 2019; left hip.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
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
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10550004
MDR Text Key207501177
Report Number1818910-2020-20426
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 consumer,other
Reporter Occupation
Type of Report Initial
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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