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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32X52-55MM 10 DEG INS DURAT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH 32X52-55MM 10 DEG INS DURAT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 6299-7-525
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Injury (2348); Osteolysis (2377)
Date of Event 06/17/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.Device not returned.
 
Event or Problem Description
As reported: "pt.Required revision due to 'some osteolysis and aseptic loosening.'" spoke to rep, patient was revised to another pca femoral head and competitor acetabular side.Rep confirmed that no further information will be released.
 
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Brand Name
32X52-55MM 10 DEG INS DURAT
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10239482
Report Number0002249697-2020-01385
Device Sequence Number13625540
Product Code JDI
UDI-Device Identifier04546540268303
UDI-Public04546540268303
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K121308
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/07/2020
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 Model Number6299-7-525
Device Catalogue Number6299-7-525
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/17/2020
Initial Report FDA Received Date07/07/2020
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 Hospitalization; Required Intervention;
Patient Age64 YR
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