MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCK TIBIAL BASEPLATE-LM/RL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180603

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

During the final impaction of the insert, the surgeon was not able to fully seat the actual insert.He had it removed and replaced with a new piece but he had the same outcome as shown on the attached photo "before further impaction" despite clearing away the surrounding tissues.This process repeated thrice and for the final insert he decided to do a further impact from the medial side and thus the final result as shown in attachment "after further impaction".A thin visible gap at the medial side can still be seen after the final further impaction.As we have exhausted all our 3x8mm polys that was prep for this case, the final poly had to be a 9mm instead.(b)(6) 2021 update: the patient was well at the moment and was discharged home.(b)(6) 2021 update: 3 attempts and 2 inserts were wasted.Lot number : 12141118-1, 12101118-1 actual insert used to complete the case, catalog number: 180703-2, lot number : 12551118-1.

Manufacturer Narrative

Additional manufacturer narrative.Reported event.An event regarding seating/locking issues involving a mako baseplate was reported.The event was not confirmed.Method & results -product evaluation and results: the reported device remains implanted however intraoperative photos were provided for review.A photo shows that an obvious gap is noticed between insert and baseplate.Another photo appears to show that the insert was locked into the baseplate after further impaction.It appears that a tiny gap was at the medial side.However, no conclusive decision can be made based on the provided photo.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that during the final impaction of the insert, the surgeon was not able to fully seat the actual insert.The reported device remains implanted however intraoperative photos were provided for review.A photo shows that an obvious gap is noticed between insert and baseplate.Another photo appears to show that the insert was locked into the baseplate after further impaction.It appears that a tiny gap was at the medial side.However, no conclusive decision can be made based on the provided photo.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

During the final impaction of the insert, the surgeon was not able to fully seat the actual insert.He had it removed and replaced with a new piece but he had the same outcome as shown on the attached photo "before further impaction" despite clearing away the surrounding tissues.This process repeated thrice and for the final insert he decided to do a further impact from the medial side and thus the final result as shown in attachment "after further impaction".A thin visible gap at the medial side can still be seen after the final further impaction.As we have exhausted all our 3x8mm polys that was prep for this case, the final poly had to be a 9mm instead.(b)(6) 2021 update: the patient was well at the moment and was discharged home.(b)(6) 2021 update : 3 attempts and 2 inserts were wasted.Lot number : 12141118-1,12101118-1.Actual insert used to complete the case, catalog number: 180703-2, lot number : 12551118-1.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 3
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 12384659
• MDR Text Key: 268705290
• Report Number: 3005985723-2021-00149
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 180603
• Device Lot Number: 26240619-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female