MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-48C
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
The surgeon for this session file case has communicated his doubts about the accuracy of the segmentation of this patient¿s ct.He highlighted that part of the femoral head seems to be segmented as the acetabulum.During the dislocation of the hip joint, this particular piece of bone (look like part of an egg shell) fell off from the acetabulum.During the registration, the overall accuracy was very bad (~0.9 to 1.0 mm) for the first 2 attempts.Most of the red spots lie within the ¿u¿ shaped of the acetabulum, almost all these red spots are shown as too deep in the bone (about 1.1 mm to 2.00 mm in bone).The fossa and the superior acetabulum registration were fine.The overall accuracy was reduced to 0.7 mm.Small amount of osteophytes was removed along the superior acetabulum before the registration, the surgeon was reminded not to register the points on the removed zone.Surgeon concluded that the inaccuracy lie within the acetabulum region, he decided to go ahead to try reaming with robot arm.After the first attempt of reaming, the pelvic checkpoint fell off and it was very difficult to re-establish the checkpoint as we are unable to conclude the registration is accuracy enough.The surgeon abandoned the robot and switch to manual mode.Now he expressed his concerns as the cup in the post-op x-ray (as attached in email) appeared to be higher superiorly than the plan.This pi is being raised to investigate the malposition of the shell post op.
Additional Manufacturer Narrative
An event regarding malposition involving a tritanium shell was reported.The event was confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review by a clinical consultant of the medical information provided concluded the following: procedure-related factors: suboptimal cup position in medialized and superior position.Patient-related factors: none device-related factors: none.Diagnosis: - ct-scan segmentation errors are common in patients with avascular necrosis of the hip and require manual override of any computer or robotic assistance systems if problems do occur.Still, the manual procedure contributed to a certain degree of cup malposition without currently however dislocation or other complications occurring.A ¿wait-and-see¿ attitude is probably the best approach at this time.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 and sterile lot provided.Conclusions: the medical review by a clinical consultant concluded the following: procedure-related factors: suboptimal cup position in medialized and superior position.Patient-related factors: none device-related factors: none.Diagnosis: ct-scan segmentation errors are common in patients with avascular necrosis of the hip and require manual override of any computer or robotic assistance systems if problems do occur.Still, the manual procedure contributed to a certain degree of cup malposition without currently however dislocation or other complications occurring.A ¿wait-and-see¿ attitude is probably the best approach at this time.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The surgeon for this session file case has communicated his doubts about the accuracy of the segmentation of this patient¿s ct.He highlighted that part of the femoral head seems to be segmented as the acetabulum.During the dislocation of the hip joint, this particular piece of bone (look like part of an egg shell) fell off from the acetabulum.During the registration, the overall accuracy was very bad (~0.9 to 1.0mm) for the first 2 attempts.Most of the red spots lie within the ¿u¿ shaped of the acetabulum, almost all these red spots are shown as too deep in the bone (about 1.1mm to 2.00mm in bone).The fossa and the superior acetabulum registration were fine.Attached is a screenshot photo taken upon the 3rd attempt for the bone registration.The overall accuracy was reduced to 0.7mm.Small amount of osteophytes was removed along the superior acetabulum before the registration, the surgeon was reminded not to register the points on the removed zone.Surgeon concluded that the inaccuracy lie within the acetabulum region, he decided to go ahead to try reaming with robot arm.After the first attempt of reaming, the pelvic checkpoint fell off and it was very difficult to re-establish the checkpoint as we are unable to conclude the registration is accuracy enough.The surgeon abandoned the robot and switch to manual mode.Now he expressed his concerns as the cup in the post-op x-ray (as attached in email) appeared to be higher superiorly than the plan.This pi is being raised to investigate the malposition of the shell post op.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM
• 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: 7285292
• Report Number: 0002249697-2018-00513
• Device Sequence Number: 11291819
• Product Code: LPH
• UDI-Device Identifier: 07613327040111
• UDI-Public: 07613327040111
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: 12/31/2022
• Device Catalogue Number: 502-03-48C
• Device Lot Number: T740Y7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/05/2018
• 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: 44 YR