MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-52D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr.Reported the following: the patient that received a constrained liner on (b)(6) luxated the liner from the tritanium cup.Dr.Mentioned that the patient is difficult to instruct.The primary surgery took place in 2014 (exeter stem and tritanium solid cup).There was an acetabular revision in 2017.An mdm liner was placed.This was luxated.Revision surgery is scheduled on (b)(6).
Additional Manufacturer Narrative
An event regarding malposition and disassociation involving a trident shell was reported.The event for malposition was confirmed however the event of disassociation was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: no interval information is available after this second revision but new stability problems in this same left hip became evident rather soon in (b)(6) 2019 that are the topic of this review.According to the provided summary information, patient presented in (b)(6) 2019 with a disassociation of the constrained bearing from the cup shell.No medical records or x-rays are available to detail these findings but another revision surgery, the third one since 2017, was scheduled for (b)(6) 2019.Two major component malposition factors active in the hip joint with non-anatomical anteversion and inclination in the arthroplasty in combination with two additional soft tissue related instability factors regarding short leg length and use of a 22-mm femoral head that may further increase capsular laxity while effective rom of a 22- mm femoral is relatively small and thereby has minimal tolerance for component malposition issues with major risk of impingement in the arthroplasty to result in hip instability ultimately leading to hip revision -product history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: no interval information is available after this second revision but new stability problems in this same left hip became evident rather soon in (b)(6) 2019 that are the topic of this review.According to the provided summary information, patient presented in (b)(6) 2019 with a disassociation of the constrained bearing from the cup shell.No medical records or x-rays are available to detail these findings but another revision surgery, the third one since 2017, was scheduled for (b)(6) 2019.Two major component malposition factors active in the hip joint with non-anatomical anteversion and inclination in the arthroplasty in combination with two additional soft tissue related instability factors regarding short leg length and use of a 22-mm femoral head that may further increase capsular laxity while effective rom of a 22-mm femoral is relatively small and thereby has minimal tolerance for component malposition issues with major risk of impingement in the arthroplasty to result in hip instability ultimately leading to hip revision.The event itself cannot be confirmed as insufficient information was provided.Further information such as device lot information, pre and post operative x-rays, operative reports as well s patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dr.Reported the following: the patient that received a constrained liner on the (b)(6) (per 2067592) luxated the liner from the tritanium cup.Dr.Mentioned that the patient is difficult to instruct.The primary surgery took place in 2014 (exeter stem and tritanium solid cup).There was an acetabular revision in 2017.An mdm liner was placed.This was luxated.Revision surgery is scheduled on(b)(6).Update(b)(6) 2019 : this event is for the 3rd revision surgery which occurred for this patient on (b)(6) 2019.Revision was due to disassociation between the trident liner and shell.Two previous revisions which occurred in 2017 on (b)(6) 2019 both relate to dislocation.An unknown exeter stem was added to the product grid in this complaint investigation based on the medical review for limb length discrepancy and migration.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM
• 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: 8745747
• Report Number: 0002249697-2019-02423
• Device Sequence Number: 2566183
• Product Code: LPH
• UDI-Device Identifier: 07613327040043
• UDI-Public: 07613327040043
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081171
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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 Catalogue Number: 500-03-52D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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