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

Catalog Number	623-10-32D
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding shell loosening was reported.Clinician review of the medical records also confirmed that the patient also had dislocation of the ceramic head from the trident liner.Method & results: product evaluation and results: material analysis of the returned devices indicated: damage consistent with contact against a hard object was observed on the proximal surface of the liner.Biological material was observed on the proximal surface of the shell.Material deformation consistent with impingement against stem was observed on the distal rim of the insert.Scratching was observed on the articulating surface of the insert; this is a common damage mode of uhmwpe.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: x-rays available for review are photographs of films on a viewing box and include an undated ap of the pelvis demonstrating bilateral uncemented total hip arthroplasty with no screws in the acetabulum.The hips are reduced and in nominal position.Another undated ap of the pelvis demonstrates a left uncemented total hip with multiple screws about the acetabulum with the plate and screws for an internal fixation of a pelvic fracture.Two additional undated aps of the pelvis are as previously described with a dislocation of the left hip and approximately a 90° migration of the acetabular component within the host pelvis.No patient demographics, no operative reports, no comprehensive clinical or past medical history, and no examination of the explanted components are available.There is no evidence that the two revisions resulting from trauma, causing a periprosthetic fracture for the first, and a dislocation and implant loosening for the second were related to factors associated with implant design, manufacturing or materials.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant indicated: x-rays available for review are photographs of films on a viewing box and include an undated ap of the pelvis demonstrating bilateral uncemented total hip arthroplasty with no screws in the acetabulum.The hips are reduced and in nominal position.Another undated ap of the pelvis demonstrates a left uncemented total hip with multiple screws about the acetabulum with the plate and screws for an internal fixation of a pelvic fracture.Two additional undated aps of the pelvis are as previously described with a dislocation of the left hip and approximately a 90° migration of the acetabular component within the host pelvis.No patient demographics, no operative reports, no comprehensive clinical or past medical history, and no examination of the explanted components are available.There is no evidence that the two revisions resulting from trauma, causing a periprosthetic fracture for the first, and a dislocation and implant loosening for the second were related to factors associated with implant design, manufacturing or materials.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The customer reported that they undertook a revision of an acetabular cup that had moved in situ.Update: patient was walking up stairs and felt something give in left hip + pain.Admitted to a&e on (b)(6) 2019 and then referred to consultant.X rays showed the cup had moved.These had been implanted on (b)(6) 2019, which was a 1st revision due to an acetabular fracture.The fracture was plated at the same time.19-sept-2019 ar.Update based on clinician review of the case: "dislocation of the left hip and approximately a 90°.Migration of the acetabular component within the host pelvis.".

• 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: 9197237
• Report Number: 0002249697-2019-03511
• Device Sequence Number: 11500808
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: 02/28/2024
• Device Catalogue Number: 623-10-32D
• Device Lot Number: 138700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/16/2019
• 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
• Patient Age: 59 YR