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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 Fall (1848); Foreign Body Reaction (1868); Unspecified Infection (1930); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)
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. 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, ¿impact of a learning curve on the survivorship of 4802 cementless total hip arthroplasties¿ by p. Magill, et al, published by the bone and joint journal (2016), vol. 98-b, no. 12, pp. 1589-1596, was reviewed. The purpose of this study is to report survivorship data and lessons learned with the corail/pinnacle cementless total hip arthroplasty (tha) system implanted between august 2005 and march 2015. Implanted depuy products: corail stem, pinnacle cup, and a variety of bearings: com, mom, coc, cop, and mop. Results: 22 revisions for joint instability- 20 head and liner exchanges; 1 cup, head, liner, and stem exchange; 1 cup, head, and liner exchange. 20 revisions for infection- 10 head and liner exchanges; 10 cup, head, liner, and stem exchanges. 15 revisions for aseptic stem loosening- 4 cup, head, liner, and stem exchanges; 11 head, liner, and stem exchanges. 6 periprosthetic intraoperative femoral fractures that were unrecognized during index surgery and treated postoperatively- 5 treated with head and stem revision; 1 treated with orif. 6 liner disassociations- 4 treated with head and liner exchanges and 2 treated with head, liner, and cup exchanges. 5 cases of metallosis associated with com and mom bearings- 2 treated with head and liner exchange; 2 treated with head, stem, and liner exchange, and 1 treated with head, liner, and cup exchange. 1 cup, head, liner, and stem revision due to a fall. 2 cup, head, liner, and stem revisions due to dislocation. 1 acetabular fracture treated with revision of the cup, head, and liner. 1 aseptic loosening of the cup treated with revision of the cup, head, and liner. 1 leg length discrepancy treated with revision of the head and stem. Captured in this complaint: 35 corail stems: implant loosening, fracture intra-op, limb asymmetry, inadequate osseointegration. 17 pinnacle cups: implant loosening, fracture post op, inadequate osseointegration. 56 acetabular liners: implant bearing wear, implant dislocation, implant disassociation, joint dislocation, foreign body reaction. 51 femoral heads: implant bearing wear, implant dislocation, foreign body reaction, joint dislocation, limb asymmetry. Patient harms applied to all components: infection, joint instability, fall, medical device removal, surgical intervention.
 
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 Key9395974
MDR Text Key185178144
Report Number1818910-2019-118667
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
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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