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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 Device Dislodged or Dislocated (2923)
Patient Problems Unspecified Infection (1930); Renal Failure (2041); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)
Event Date 02/15/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
"literature article entitled, ¿a modern constrained acetabular component for the management of hip instability¿ by dror maor, et al, published by journal of musculoskeletal research (2016), vl. 19, no. 1, article id 1650002, 7 pages, doi: 10. 1142/s0218957716500020, was reviewed. The authors report clinical and radiological findings in 76 patients treated with a constrained liner for those considered at high-risk for dislocation, intraoperative instability or recurrent dislocations. Mean follow up was 12 months. Post operatively there were two cases of recurrent dislocation, one aseptic loosening and nine cases of deep infection. These results support that these liners have been used to treat, or in some cases prevent, instability after total hip replacement. Implanted products: this study reports the clinical and radiological findings in patients treated with the pinnacle constrained liner (depuy) for those considered at high-risk for dislocation, intraoperative instability or recurrent dislocation. The acetabular cup is the uncemented pinnacle cup in 74 patients and 2 cemented pinnacle cups. The median femoral head size was 32-mm. There was a median of two screws used to secure uncemented cups. The make and manufacturer of the femoral stem are unknown. Results: 7 grade 1 and 4 grade 2 heterotopic ossification. 1 revision of the liner for osteolysis and dislocation. 15 cases of serial radiographically confirmed osteolysis (liner and head)- no revision or intervention. 2 cases progressive loosening of cup radiographically identified, treatment unspecified. 1 revision for dislocation. 1 revision for deep infection and dislocation of spacer from liner during the two-stage revision to treat this deep infection. Manufacturer of the temporary spacer is unknown. 6 superficial wound infections treated with antibiotic. 1 deep infection and dislocation- converted to girdlestone due to inability to control infection. 4 ¿cardiac events¿. Events and treatment are unspecified. 4 ¿chest infections¿. 2 advanced into renal failure. Treatment and type of chest infections are unspecified. 1 asymptomatic aseptic cup loosening not revised due to patient comorbidities making them unable to tolerate surgical intervention. 5 additional deep infections: i treated with l & d and liner exchange, 1 treated with i & d only, 3 treated with long-term oral antibiotics there was a total of 7 reoperations in this study. The stem is unknown. Therefore, the revision of the stem for loosening is not captured in this complaint. Captured in this complaint: pinnacle cup, pinnacle constrained liner, unknown femoral head. There were no reported events associated with the screws used to secure some of the uncemented cups. There were no reported events associated with the two cemented pinnacle cups. The types of the chest infections are unknown, and are captures as ""infections"" in this complaint. They types of cardiac events are unknown and are therefore not captured within the guidance document but included in the event description. ".
 
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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
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9216213
MDR Text Key163117826
Report Number1818910-2019-108701
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
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 Received12/19/2019
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: 10/21/2019 Patient Sequence Number: 1
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