MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-32E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At five years postoperative, the subject reported very good health and moderate pain or discomfort in the study hip.At this point, he answered ¿no¿ to being satisfied with his study hip replacement.The study coordinator believes it is possible the subject marked "no" in error as the questionnaires were completed via mail and the subject never expressed any dissatisfaction with his hip replacement.At six years postoperative, the subject answered ¿yes¿ to being satisfied with his study hip replacement on patient questionnaires.
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been 1 similar event for the lot referenced.The following devices were also listed in this report: 127 size 9 secur-fit advanced stem; cat#1601-09127; lot# mmloth.Primary tritanium hemi cluster hole cup 54mm; cat#502-03-54e; lot#7132wp.Delta v-40 ceramic head 32/+4; cat# 6570-0-232; lot# 51386805.Acetabular dome hole plug; cat#2060-0000-1; lot#4n38x0.6.5 cancellous bone screw 30mm; cat#2030-6530-1; lot# we3l11.6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot# da2hrj.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.
Additional Manufacturer Narrative
Mfr report #0002249697-2022-00937 was reported in error.This pi reports the patient¿s response to a study with his hip replacement where he answered ¿no¿ to being satisfied.The study coordinator believes it is possible the subject marked "no" in error.No adverse events were reported, therefore, this complaint is being cancelled.
Event or Problem Description
At five years postoperative, the subject reported very good health and moderate pain or discomfort in the study hip.At this point, he answered ¿no¿ to being satisfied with his study hip replacement.The study coordinator believes it is possible the subject marked "no" in error as the questionnaires were completed via mail and the subject never expressed any dissatisfaction with his hip replacement.At six years postoperative, the subject answered ¿yes¿ to being satisfied with his study hip replacement on patient questionnaires.

• Brand Name: TRIDENT 0° X3 INSERT 32MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14844872
• Report Number: 0002249697-2022-00937
• Device Sequence Number: 14049089
• Product Code: LPH
• UDI-Device Identifier: 07613327039450
• UDI-Public: 07613327039450
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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 Expiration Date: 05/31/2020
• Device Model Number: 623-00-32E
• Device Catalogue Number: 623-00-32E
• Device Lot Number: N83XVN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White