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

Model Number	502-11-54E
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/1948
Type of Reportable Event	Malfunction
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A voluntary recall was initiated for trident® hemispherical acetabular shells, encompassing all lot codes with an expiration dates between january 1, 2003 and december 31, 2012.
Event or Problem Description
Patient called stating she had a left hip replacement done on october 24, 2007 and wants to know if her implants are part of a recall.Patient is asymptomatic at the time of this call.
Additional Manufacturer Narrative
Reported event: an event regarding a recall query involving a trident shell was reported.Conclusion: patient called stating she had a left hip replacement done on (b)(6) 2007 and wants to know if her implants are part of a recall.Patient is asymptomatic at the time of this call.Based on review, it has been confirmed that the reported device involved in recall pfa# 2008-005.The complaint was solely submitted regarding a recall query, the patient is asymptomatic and no device issues were reported.No further investigation is required at this time.If additional information becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
Patient called stating she had a left hip replacement done on (b)(6) 2007 and wants to know if her implants are part of a recall.Patient is asymptomatic at the time of this call.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE 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: 9688799
• Report Number: 0002249697-2020-00255
• Device Sequence Number: 16989575
• Product Code: LPH
• UDI-Device Identifier: 04546540432049
• UDI-Public: 04546540432049
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 07/31/2012
• Device Model Number: 502-11-54E
• Device Catalogue Number: 502-11-54E
• Device Lot Number: 23447501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1168/74-2008
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 73