MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0737
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	04/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding subsidence involving a accolade stem 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: " 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 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.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.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 or Problem Description
It was reported by claimants attorney that meredith 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.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 (b)(6) 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 (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 1-centimeter subsided.".

• Brand Name: SIZE 7 ACCOLADE II 132 DEG
• 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: 7663744
• Report Number: 0002249697-2018-02070
• Device Sequence Number: 2355190
• Product Code: LPH
• UDI-Device Identifier: 04546540664501
• UDI-Public: 04546540664501
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 6720-0737
• Device Lot Number: 43661804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/05/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 102