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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 SLF TAPPING ROOF PILE SCRW40MM; HIP OTHER IMPLANT
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DEPUY ORTHOPAEDICS, INC.1818910 SLF TAPPING ROOF PILE SCRW40MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 101140040
Device Problems Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Pain (1994)
Event Date 01/27/2014
Event Type  Injury  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address cup loosening and pain.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Patient was revised to address cup loosening and pain.Update recv'd 03/07/2014 - patient's medical records were received.Records indicate upon revision it was noticed the patient had metallosis from where the loose screws and triflange cup were meeting with a resultant pseudotumor formation.Upon removal of the acetabular cup a low transverse fracture created a pelvic disassociation.Also noted, was a screw that had migrated medially and one that was broken and retained in the ilium due to osteolysis.At this time it is unknown which screw had migrated and which had broken.(b)(4).The devices associated with this report were not returned.A review of the device history records for the d5ldl1000, d13pk1000 and c4gde1000 lot codes did not reveal any related manufacturing deviations or anomalies.A complaint database search finds no other related incidents against the remaining product and lot combinations.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.Medical records were obtained and reviewed by a medical professional.From a medical perspective based on the information available, it is unlikely the complaint is product related.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
SLF TAPPING ROOF PILE SCRW40MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
stacey trick
700 orthopaedic drive
warsaw, IN 46581
5743714554
MDR Report Key3628165
MDR Text Key11599816
Report Number1818910-2014-12616
Device Sequence Number1
Product Code JDJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK932007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number101140040
Device Lot NumberC4GDE1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
Patient Weight73
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