MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SYMMETRIC PATELLA CAPTURE S33; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 6541-3-339

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348)

Event Date 09/07/2018

Event Type  Injury  

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.Device not returned.

Event Description

Primary tka was performed on (b)(6) 2018.Patient complained of knee pain and had difficulty in therapy.Approximately 3 weeks later the patient was in the clinic to see dr for a follow up on post op issues.X-rays reveal there was a symmetric patella capture implanted on the patella implant in the patient.The patient was then scheduled for a revision tka.The revision was successful in removing the symmetric patella capture.Update 10/september/2018: as cited in "adverse consequences details": range of motion was not achieved.Rep advised that none of the reported implants were revised.Only the patella capture (not the patella) was removed.Pre-revision x-rays, primary operative report, and usage sheet are provided.

Event Description

Primary tka was performed on (b)(6) 2018.Patient complained of knee pain and had difficulty in therapy.Approximately 3 weeks later the patient was in the clinic to see dr for a follow up on post op issues.X-rays reveal there was a symmetric patella capture implanted on the patella implant in the patient.The patient was then scheduled for a revision tka.The revision was successful in removing the symmetric patella capture.Update 10/september/2018: as cited in "adverse consequences details": range of motion was not achieved.Rep advised that none of the reported implants were revised.Only the patella capture (not the patella) was removed.Pre-revision x-rays, primary operative report, and usage sheet are provided.

Manufacturer Narrative

Adding investigation conclusion; reported event: an event regarding user error in disassembling the patella capture from the patellar component during surgery was reported.The event was confirmed through review of the provided medical records by a clinical consultant.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: x-ray printouts available for review include a series dated (b)(6) 2018, which are two laterals of the left knee, demonstrating an uncemented left total knee arthroplasty.All components are in nominal position, however a radio dense shadow posterior to the patella consisting with the retained patellar capture device is noted.No patient demographics, no clinical or past medical history, and no revision operative report is available.The inadvertent retention of an implantation device was the source of the clinical problem in this case and was not related to any factors associated with the retained total knee arthroplasty components.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event regarding user error in disassembling the patella capture from the patellar component during surgery was confirmed through review of the provided medical records by a clinical consultant.The investigation concluded that a review of the provided medical records and/or x-rays by a clinical consultant indicated: x-ray printouts available for review include a series dated (b)(6) 2018, which are two laterals of the left knee, demonstrating an uncemented left total knee arthroplasty.All components are in nominal position, however a radio dense shadow posterior to the patella consisting with the retained patellar capture device is noted.No patient demographics, no clinical or past medical history, and no revision operative report is available.The inadvertent retention of an implantation device was the source of the clinical problem in this case and was not related to any factors associated with the retained total knee arthroplasty components.It is stated in the applicable surgical protocol that the patella capture should be removed from the patellar component during surgery, after the patellar component is secured into position.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SYMMETRIC PATELLA CAPTURE S33
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7934143
• MDR Text Key: 122664157
• Report Number: 0002249697-2018-03188
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327195866
• UDI-Public: 07613327195866
• Combination Product (y/n): N
• PMA/PMN Number: K172326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 6541-3-339
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR