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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYS 12 28MM NEU DURATN INS P2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SYS 12 28MM NEU DURATN INS P2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 6302-5-062
Medical Device Problem Codes Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 10/06/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation 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 similar events for the lot referenced.
 
Event or Problem Description
It was reported that the patient's hip was revised due to eccentric wear of the poly liner and instability.A head and liner exchange was performed.Rep confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
SYS 12 28MM NEU DURATN INS P2
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MDR Report Key12749825
Report Number0002249697-2021-01826
Device Sequence Number1453858
Product Code LPH
UDI-Device Identifier04546540269652
UDI-Public04546540269652
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
PMA/510(K) Number
K993352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2001
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date04/30/2004
Device Model Number6302-5-062
Device Catalogue Number6302-5-062
Device Lot NumberVSIJA
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/06/2021
Initial Report FDA Received Date11/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured04/30/1999
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age84 YR
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