MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-36G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/13/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
Our legal departement reported a claim by the lawyer of a patient implanted with a trident, hipstar and v40 head at hospital on (b)(6) 2009.Products involved seem to be trident, hipstar and v40 head.The claim states that the patient underwent a revision surgery due to dislocation of the head.
Event or Problem Description
Our legal departement reported a claim by the lawyer of a patient implanted with a trident, hipstar and v40 head at hospital on (b)(6) 2009.Products involved seem to be trident, hipstar and v40 head.The claim states that the patient underwent a revision surgery due to dislocation of the head.
Additional Manufacturer Narrative
This event was identified as a duplicate of (b)(4).Investigation results and conclusion to be documented under mfr #0002249697-2018-00383.

• Brand Name: TRIDENT 10° X3 INSERT 36MM 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: 9419041
• Report Number: 0002249697-2019-03964
• Device Sequence Number: 2423951
• Product Code: LPH
• UDI-Device Identifier: 07613327039931
• UDI-Public: 07613327039931
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 09/30/2013
• Device Catalogue Number: 623-10-36G
• Device Lot Number: 28073801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: Hospitalization; Required Intervention