MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL-R-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180414

Device Problems Corroded (1131); Contamination /Decontamination Problem (2895); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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 Description

The implant was found contaminated in the packaging at the time of opening for implantation, so we didn't use it and opened a new one.On (b)(6) 2019 update via phone with sales rep: there was no damage noted on the outer blister.The inner blister appeared to have discoloration.The implant also appeared to be discolored.Case type: pka.Surgical delay: x - =15 minutes.Update: "the implant was discovered as faulty immediately upon opening and did not make contact with the patient.The scrub tech did not observe or comment on any tears or openings in the blister packaging prior to opening.The blemish is on the center of the implant in the trochlear groove.It appears as though the metal tarnished in some way.I was not able to wipe or scrape off the blemish using a wipe or tool.It was additionally observed where the inner blister packaging was contacting the blemish, the packaging turned yellow.Right patellofemoral mako".

Manufacturer Narrative

An event regarding packaging issue involving a mako patellofemoral component was reported.The event was confirmed via product inspection.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019.This inspection indicated that ¿the part was examined with the aid of a stereo microscope at magnifications up to 50x.An irregularity was observed on the articulating surface of the implant.Localized scratching was observed on the articulating surface around and through the surface irregularity; which is consistent with the reported attempt to remove it.The articulating surface was analyzed further using a scanning electron microscope (sem).¿ material analysis: material evaluation was completed and indicated ¿a surface irregularity was observed on the articulating surface of the implant consistent with an oxide and a corrosion product.The implant base material is consistent with an astm f75 alloy.¿ functional and dimensional inspection: not performed as these aspects are not in question.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all 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 reported lot.Conclusion: material evaluation was completed and indicated ¿a surface irregularity was observed on the articulating surface of the implant consistent with an oxide and a corrosion product.The implant base material is consistent with an astm f75 alloy.¿ the product manufacturer reviewed the event and stated the following: -total lot quantity of 62 was sold out of cdc (distribution center).No other complaints reported for this lot.-all implants are inspected 100% after passivating and cleaning per mako qip 0029 by orchid ortho.Orchid found no issues with the lot.-all implants are inspected 100% at millstone fall river.Millstone found no issues during the 100% inspection.-parts were out of millstone for 2 years before receiving the complaint.-due to all controls and the length of time the product was out there we cannot confirm the origin of the nonconformance.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 Description

The implant was found contaminated in the packaging at the time of opening for implantation, so we didn¿t use it and opened a new one.(b)(6) 2019 update via phone with sales rep: there was no damage noted on the outer blister.The inner blister appeared to have discoloration.The implant also appeared to be discolored.Case type: pka surgical delay: x - =15 minutes update: "the implant was discovered as faulty immediately upon opening and did not make contact with the patient.The scrub tech did not observe or comment on any tears or openings in the blister packaging prior to opening.The blemish is on the center of the implant in the trochlear groove.It appears as though the metal tarnished in some way.I was not able to wipe or scrape off the blemish using a wipe or tool.It was additionally observed where the inner blister packaging was contacting the blemish, the packaging turned yellow.Right patellofemoral mako".

• Brand Name: MCK PATELLOFEMORAL-R-SZ 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8691248
• MDR Text Key: 147885767
• Report Number: 3005985723-2019-00424
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000493
• UDI-Public: 00848486000493
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 180414
• Device Catalogue Number: 180414
• Device Lot Number: 2607851-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR