MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL RESECTION GUIDE - STANDARD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	6541-1-721
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional 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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Triathlon distal femoral resection guide was set to 10mm.The amount of bone that was cut was more than 10mm.Dr.Measured the gap between the universal resection guide and the mis adjustment block that was placed in the femoral alignment guide.The doctor measured that gap at 13mm.Doctor said joint line was elevated and he needed to use a 16mm poly.
Additional Manufacturer Narrative
An event regarding a size/fit issue involving a triathlon guide was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed on the returned guide.There are scratches and wear marks on multiple surfaces of the device.A functional inspection was performed with the returned device which was assembled to, remained locked to and disassembled from 6541-5-601 lot code rd9l153 which was returned with this device.Examination of the returned device with engineer indicated that the device is worn due to in service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: 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: visual inspection was performed on the returned guide.There are scratches and wear marks on multiple surfaces of the device.A functional inspection was performed with the returned device which was assembled to, remained locked to and disassembled from 6541-5-601 lot code rd9l153 which was returned with this device.Examination of the returned device with engineer indicated that the device is worn due to in service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Triathlon distal femoral resection guide was set to 10mm.The amount of bone that was cut was more than 10mm.Dr.Measured the gap between the universal resection guide and the mis adjustment block that was placed in the femoral alignment guide.The doctor measured that gap at 13mm.Doctor said joint line was elevated and he needed to use a 16mm poly.

• Brand Name: DISTAL RESECTION GUIDE - STANDARD
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8804334
• Report Number: 0002249697-2019-02600
• Device Sequence Number: 457268
• Product Code: MBH
• UDI-Device Identifier: 07613327240368
• UDI-Public: 07613327240368
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K123486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 6541-1-721
• Device Lot Number: 135804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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: Other
• Patient Age: 71 YR
• Patient Weight: 93