MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-54E
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The product was packaged off center in the plastic tub and the rough surface of the shell rubbed against the plastic.It created plastic particles in the shell.
Additional Manufacturer Narrative
An event regarding a packaging issue involving a tritanium shell was reported.The event was not confirmed.
Event or Problem Description
The product was packaged off center in the plastic tub and the rough surface of the shell rubbed against the plastic.It created plastic particles in the shell.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6901507
• Report Number: 0002249697-2017-02872
• Device Sequence Number: 483278
• Product Code: LPH
• UDI-Device Identifier: 07613327040012
• UDI-Public: 07613327040012
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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 Date: 07/31/2022
• Device Catalogue Number: 500-03-54E
• Device Lot Number: A86X7H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 12/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR