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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 Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4). (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. (b)(4).
 
Event Description
Literature article abstract entitled, ¿outcome of a hemispherical porous-coated acetabular cup with proximally hydroxyapatite-coated anatomic stem. A concise follow-up report at a mean of twenty years¿ by carbonell escobar r. , et al, found in abstracts from the 12th congress of the european hip society (2016), page s12, abstract number op03-64, was reviewed. The purpose of this abstract is to report the updated results at 20 years for a previously reported cohort of patients who underwent a single updated total hip replacement. Implanted depuy products: duraloc cup, profile stem, 28-mm polyethylene liner, and a femoral head were used in all patients. Results: 6 cups and liners were revised due to polyethylene wear 1 mispositioned cup- there is insufficient information provided within the text of the abstract to determine if treatment was required. 5 cups, heads and liners were revised due to late dislocations. All revised cups showed were well-fixed and osseointegrated during surgical revision. Captured in this complaint: 1 duraloc cup: implant misposition. 11 polyethylene liners: implant bearing wear and implant dislocation. 5 femoral heads: implant dislocation. Patient harms: joint dislocation, medical device removal, surgical intervention. The 11 cups revised due to polyethylene wear and dislocation had no reported product problems. There is insufficient information provided to attribute the polyethylene wear and dislocations to the cup.
 
Manufacturer Narrative
Product complaint # (b)(4). (b)(4) to capture medical device removal. Investigation summary
==
> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. Investigation methods: was patient affected: yes. Device history reviewed: no. Lot trace obtained: no. Complaints database searched: no. Product checked: no. Label checked: no. Product pulled from stock for inspection: no. A review of complaint databases was not possible as no product details were received. It should be noted that no device was returned. Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution. The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon. From the event information received, it was not possible to determine the relationship of the device to the reported event. No information received with this individual complaint indicated that a broader investigation or corrective action was necessary. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis. Post market surveillance is per (b)(4).
 
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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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9396026
MDR Text Key185553640
Report Number1818910-2019-118637
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
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 Treatment Data
Date Received: 12/02/2019 Patient Sequence Number: 1
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