MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-32E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
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.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.
Event or Problem Description
During a tha and at poly impaction stage, the surgeon noticed in the wound a small foreign body resembling a plastic string.This was noticed near the poly / shell area and measured approximately 1.5/2 com.The foreign body was removed and sent for analysis.The surgeon wanted this recorded in a pi.Update: were any additional steps taken to ensure all foreign bodies were removed from the patient? 1.If so, what were they? wash out of the surgical site with abundant normal saline irrigation / suction - was any additional medical intervention (intra- or post-op) taken? no.Left or right side: left side.

• Brand Name: TRIDENT 10° 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
• MDR Report Key: 9569219
• Report Number: 0002249697-2020-00062
• Device Sequence Number: 492195
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: 08/31/2024
• Device Catalogue Number: 623-10-32E
• Device Lot Number: EY64TL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/09/2020
• 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: 51 YR