MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BACK SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-11-54E
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that while performing a procedure of patient's left hip, the cup had scratches inside.Rep reported that all packaging was intact.The rep took a photo of the implant and circled the affected area with marker.The rep reported that a backup device was immediately available (no surgical delay).
Additional Manufacturer Narrative
Product available to stryker.An event regarding appearance issue involving a trident shell was reported.The event was not confirmed.Visual inspection was carried out on the photograph supplied by the sales rep, no device was returned, the photograph showed a scratch like mark approx 1 cm in length on the inside surface of the shell, it had been circled in pen by the sales rep.A medical review was not performed because no medical information was provided.Review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Review indicated there have been no other similar events for the reported lot.Consulation with the manufacturing cell indicated that the device conformed to the required specifications at time of manufacture.The exact cause of the event could not be determined because the device was not returned.Returned of the device is needed to complete the investigation for determining root cause.No further investigation is required.If further relevant information becomes available this investigation will be re-opened.
Event or Problem Description
It was reported that while performing a procedure of patient's left hip, the cup had scratches inside.Rep reported that all packaging was intact.The rep took a photo of the implant and circled the affected area with marker.The rep reported that a backup device was immediately available (no surgical delay).

• Brand Name: TRIDENT HEMISPHERICAL SOLID BACK SHELL
• 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: 7086258
• Report Number: 0002249697-2017-03477
• Device Sequence Number: 1798981
• Product Code: LPH
• UDI-Device Identifier: 04546540431875
• UDI-Public: 04546540431875
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• 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): 02/01/2018

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 Date: 08/09/2022
• Device Catalogue Number: 500-11-54E
• Device Lot Number: 60599803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 02/01/2018
• 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: 44 YR