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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
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STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU Back to Search Results
Catalog Number 17-3200E
Medical Device Problem Code Noise, Audible (3273)
Health Effect - Clinical Codes Pain (1994); Injury (2348)
Date of Event 07/11/2018
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.
 
Event or Problem Description
It was reported that patient's right hip was revised due to pain and audible noise.Patient was revised from a ceramic head and liner to a 36 +5 ceramic head with 36e poly liner.
 
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Brand Name
ALUMINA C-TAPER HEAD 32MM/0
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7763589
Report Number0002249697-2018-02450
Device Sequence Number11092621
Product Code LZO
UDI-Device Identifier07613327101249
UDI-Public07613327101249
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K971409
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/08/2018
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 Catalogue Number17-3200E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2018
Initial Report FDA Received Date08/08/2018
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 Hospitalization; Required Intervention;
Patient Age51 YR
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