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

Model Number	623-00-32D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, an ae for bursitis was reported.The subject¿s chief complaint was left hip and thigh pain, as well as tenderness over the greater trochanter (gt) and it band.Treatments have included lortab on (b)(6) 2017, physical therapy on september 18, 2019 and multiple steroid injections in march and april 2017, as well as january and august of 2019.The subject reported ¿no¿ to being satisfied with her study hip replacement at the 5 year visits.The subject commented that her pain has worsened compared to her preoperative state and was very disappointed.
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 have been no other similar events for the lot referenced.The following devices were also listed in this report: 127 size 6 secur-fit advanced stem; cat#1601-06127; lot#mmm5ha, primary tritanium hemi cluster hole cup 50mm; cat#502-03-50d; lot#8920mx, 32mm +8 lfit v40 head; cat# 6260-9-332; lot# 49222701, acetabular dome hole plug; cat#2060-0000-1; lot#d35w8l, 6.5 cancellous bone screw 35mm; cat# 2030-6535-1; lot#mnka5a, 6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot#mnkp62.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM HEAD
• 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: 14656080
• Report Number: 0002249697-2022-00817
• Device Sequence Number: 14846449
• Product Code: LPH
• UDI-Device Identifier: 07613327039467
• UDI-Public: 07613327039467
• 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
• Report Date (Section B): 06/10/2022

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: 07/31/2020
• Device Model Number: 623-00-32D
• Device Catalogue Number: 623-00-32D
• Device Lot Number: P66T8T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 66 KG