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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID36 OD52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID36 OD52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 63093652
Medical Device Problem Code Detachment Of Device Component (1104)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/27/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
 
Event or Problem Description
Customer noticed that 2 cement spacers had fallen of the implant when opening the box.They then opened another and used that one.
 
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Brand Name
EXETER X3 RIMFIT ID36 OD52
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7373974
Report Number0002249697-2018-00894
Device Sequence Number1147062
Product Code JDI
UDI-Device Identifier07613327072280
UDI-Public07613327072280
Combination Product (Y/N)N
Initial Reporter CountrySE
PMA/510(K) Number
K111848
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2021
Device Catalogue Number63093652
Device Lot NumberLFE006
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/27/2018
Initial Report FDA Received Date03/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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