MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 542-11-52E

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Injury (2348); Joint Dislocation (2374); No Information (3190)

Event Date 04/28/2015

Event Type  Injury  

Manufacturer Narrative

Additional information is not available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report.

Event Description

It was reported by claimants attorney that patient was implanted with a trident hip psl ha cluster and liner on or about (b)(6) 2015, which failed, resulting in a replacement surgery on or about (b)(6) 2015.

Manufacturer Narrative

Additional information: a patient information; d1 brand name; d2 product code; d2 common device name; d4 catalog #; d4 lot #, d4 expiration date; d4 unique identifier (udi) #; g5 pma/510(k) #; h4 device manufacture date.An event regarding disassociation involving a trident shell was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: not performed as the product was not returned.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant revealed: " on march 17, 2015 the patient underwent a left total hip arthroplasty and removal of hardware for a diagnosis of post-traumatic degenerative joint disease of the left hip.The operative report describes general anesthesia and a posterolateral approach.The operative report noted extensive heterotopic ossification and the hip was stiff and was unable to be dislocated so a femoral neck osteotomy was performed in situ.An office visit note for april 6, 2015 states, "complaining of left groin pain.X-ray: liner of the acetabulum.Disassociated." the plan was revision.X-rays dated (b)(6) 2015 are two ap' s of the left hip demonstrating an uncemented left total hip arthroplasty with no screws in the acetabulum.The pelvic internal fixation hardware remains in situ.Increased heterotopic ossification is noted.The stem is subsided approximately i-centimeter and the head is not deeply seated in the acetabulum, which may represent a subluxated insert, however poor resolution of the x­ ray is noted on this and multiple intraoperative x-rays.X-rays dated (b)(6), 2015 are multiple views of the left hip demonstrating the uncemented total hip with the liner disassociated and the stem once again noted to be i-centimeter subsided.No examination of the explanted components is available for review.Information provided that "geisinger medical center has informed us that the explanted components were discarded at the time of the second surgery." in this difficult primary total hip arthroplasty there is no evidence the acetabular liner was ever successfully locked in place at the initial surgery.Ifwe had the explanted components to examine, we may have been able to determine if they were ever successfully locked in place at the initial surgery.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation." -product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.- complaint history review: there have been no other events for the lot referenced.Conclusions: the event was confirmed by medical review but the root cause could not be determined as no devices were returned for evaluation.Review of the medical review stated " no examination of the explanted components is available for review.Information provided that "geisinger medical center has informed us that the explanted components were discarded at the time of the second surgery." in this difficult primary total hip arthroplasty there is no evidence the acetabular liner was ever successfully locked in place at the initial surgery.If we had the explanted components to examine, we may have been able to determine if they were ever successfully locked in place at the initial surgery.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation." if additional information is received, this investigation will be reopened and re-evaluated.

Event Description

It was reported by claimants attorney that patient was implanted with a trident hip psl ha cluster and liner on or about 03/17/2015, which failed, resulting in a replacement surgery on or about (b)(6) 2015.Update as per medical review received stated " an office visit note for (b)(6), 2015 states, "complaining of left groin pain.X-ray: liner of the acetabulum.Disassociated." the plan was revision.On april 28, 2015 a revision of the left total hip arthroplasty, all components, was performed for a diagnosis of dislocated acetabular shell.The stem is subsided approximately 1-centimeter and the head is not deeply seated in the acetabulum, which may represent a subluxated insert, however poor resolution of the x-ray is noted on this and multiple intraoperative x-rays.X-rays dated april 6, 2015 are multiple views of the left hip demonstrating the uncemented total hip with the liner disassociated and the stem once again noted to be 1-centimeter subsided.".

• Brand Name: TRIDENT PSL HA CLUSTER 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5316254
• MDR Text Key: 34047364
• Report Number: 0002249697-2015-04434
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 542-11-52E
• Device Lot Number: MNN6T2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 102