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

Catalog Number	623-10-32H
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Lot id: there have been no other similar events for the reported lot.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.Device not returned.
Event or Problem Description
Surgeon providing the surgery claimed: despite the use of the correct surgical technique, implantation of the insert was impossible (several attempts).As a result, a second implant was used.During surgery the surgeon decided to use a insert 28h instead of 32h replacement was available.
Event or Problem Description
Surgeon providing the surgery claimed: despite the use of the correct surgical technique, implantation of the insert was impossible (several attempts).As a result, a second implant was used.During surgery the surgeon decided to use a insert 28h instead of 32h replacement was available.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving a trident liner was reported.The event was not confirmed.Damage observed on insert consistent with attempted implantation in addition to explantation process.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No medical records were received for review with a clinical consultant.All devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The reported event cannot be confirmed as the device was returned damaged.Dimensional inspection is not possible as the was returned damaged and in its current condition would not be an accurate reflection of it¿s original manufactured condition.No further investigation is possible at this time.If additional information becomes available the investigation will be reopened.

• 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: 7990254
• Report Number: 0002249697-2018-03448
• Device Sequence Number: 1255827
• Product Code: LPH
• UDI-Device Identifier: 07613327039887
• UDI-Public: 07613327039887
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K033716
• 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): 12/19/2018

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: 10/31/2022
• Device Catalogue Number: 623-10-32H
• Device Lot Number: 61765201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 100