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

Catalog Number	500-11-48D
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Nurse informed that the inside of the shell has a scratch.Customer used another shell.
Additional Manufacturer Narrative
Corrected data: - expiration date.Additional information: - gtin; product available to stryker.An event regarding appearance issue involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection -- a visual inspection was performed on the returned device noted that no scratches were present on the inside or outside of the device.Dimensional inspection: not performed as reported event is not related to the dimensional integrity of the device.Functional inspection: not performed as reported event is not related to device function.Material analysis: not performed as reported event is not related to material integrity.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed.There were no scratches present on the returned device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Nurse informed that the inside of the shell has a scratch.Customer used another shell.

• 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: 7442547
• Report Number: 0002249697-2018-01165
• Device Sequence Number: 1769400
• Product Code: LPH
• UDI-Device Identifier: 04546540431844
• UDI-Public: 04546540431844
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 01/31/2023
• Device Catalogue Number: 500-11-48D
• Device Lot Number: 62811401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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