MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-54E
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding disassociation of a metal head from an accolade stem was reported.Malposition of the tritanium shell was identified by a clinician during medical review.Method & results: product evaluation and results: could not be performed as the device remain implanted in the patient.Medical records received and evaluation: a review by a clinician of the medical information provided noted the following: principal factor to contribute to the adverse event relates to cup malposition in excessively low inclination with the shell in 29° of inclination where the documented use of a 10° x3 bearing decreases the effective inclination of the entire cup construct to even lower values around 20° of inclination.Target value for optimal inclination is between 40° - 45°.Cup anteversion is on the high side of normal but probably not really pathological.Cup malposition in low inclination causes impingement between stem neck and cup/liner rim with an overload condition developing in the bearing section.Of further relevance is the fact that the cup shell was retained.This means that cup malposition may continue to contribute to overload effects even though this time a 0° offset liner was used, making the degree of malposition less extreme.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 were no other events for the lot provided.Conclusions: the medical review concluded the following: cup malposition in very low inclination with additional inappropriate use of a 10° cup liner in a cup shell with already low inclination plus further additional heterotopic ossifications in the joint have contributed together to an overload condition in the arthroplasty leading to excessive corrosion in the taper junction with gradual loss of taper lock functionality and ultimately disassociation between femoral head and trunnion requiring revision surgery.Does the review identify any procedural related factors that contributed to the event? cup malposition in low inclination (29°); inappropriate use of a 10° cup liner in a cup shell with already low inclination.Does the review identify any patient related factors that contributed to the event? heterotopic ossifications in the joint space (brooker grade-3).Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices, consistent with explant materials analysis findings where it was reported that ¿damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock¿.No further investigation for this event 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
"patient¿had a primary hip arthroplasty performed¿on (b)(6) 2011¿ on or about (b)(6) 2018 the patient was raking leaves and heard a pop.The patient was seen by [surgeon] on or about (b)(6) 2018 and based on examination and x-ray there was radiographic evidence to perform a femoral head and x3 polyurethane swap or total hip revision that following wednesday ((b)(6) 2018).The course of action was to be determined intra-operatively.When [surgeon] opened the hip capsule, he stated that the capsule fluid and surrounding tissue was black with suspected metallosis.[surgeon] proceeded to incise, drain and lavage the surrounding area of affected tissue.He stated that the stem of the femoral neck was broken, and the x3 poly was cracked.He removed the broken neck, x3 poly and femoral head.He proceeded to start the removal of the femoral stem.An accolade stem inserter was screwed into the stem.He utilized osteotomes to try to separate bone from the prosthesis.A double ring extractor in conjunction with the accolade inserter were used to back slap the stem from the femoral canal.At some point during the removal of the [stem], the femur was cracked.A restoration modular revision stem, x3 poly, biolox femoral head and three dall miles cables were implanted¿" update 21 january, 2019: material analysis and med review has been carried out on this case.Mar confirmed damage on the stem trunnion and head taper consistent with cyclical contact after loss of taper lock.Corrosion was also confirmed by the mar.Medical review confirmed head stem disassociation, impingement between stem and liner, heterotopic ossifications leading to bone impingement, intra operative femoral fracture, shell malposition and inappropriate use of 10 degree liner.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• 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: 8338842
• Report Number: 0002249697-2019-01049
• Device Sequence Number: 11251440
• Product Code: LPH
• UDI-Device Identifier: 07613327040142
• UDI-Public: 07613327040142
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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: 11/30/2015
• Device Catalogue Number: 502-03-54E
• Device Lot Number: MJPYRJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/14/2019
• 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: 60 YR