MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID PS TIBIAL INSERT TRIAL SIZE 2 - 14MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	5532-T-214Y
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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.The following devices were also listed in this report: triathlon solid ps tibial insert trial size 2 - 19mm; cat#: 5532-t-219y; lot#: a1qax.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
In in-coming inspection at distribution, it was found that the item number on the label and the item number on the unit didn't match.This event was found on 1 of 15pcs of 5532-t-214y, lot# a1qcw, received on po# 60088308, inv# 50565638.Item#: (label): 5532-t-214y, item#: (unit): 5532-t-219y.
Event or Problem Description
In in-coming inspection at distribution, it was found that the item number on the label and the item number on the unit did not match.This event was found on 1 of 15pcs of 5532-t-214y, lot#: a1qcw, received on po#: (b)(4), inv#: (b)(4).Item#: (label) : 5532-t-214y; item#: (unit) : 5532-t-219y.
Additional Manufacturer Narrative
Reported event: an event regarding product mix involving a triathlon trial was reported.The event was confirmed on review of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device found a device with a label which states catalogue number 5532-t-214y while a review of the device in the actual bag found a device with catalogue number 5532-t-219y engraved on device material analysis, functional and dimensional inspections were not performed as these aspects are not in question.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 have been no other similar events for the lot referenced.Conclusions: visual inspection of the returned device found a device with a label which states catalogue number 5532-t-214y while a review of the device in the actual bag found a device with catalogue number 5532-t-219y engraved on device.

• Brand Name: TRIATHLON SOLID PS TIBIAL INSERT TRIAL SIZE 2 - 14MM
• 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: 9884469
• Report Number: 0002249697-2020-00606
• Device Sequence Number: 19529195
• Product Code: LPH
• UDI-Device Identifier: 07613327404265
• UDI-Public: 07613327404265
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 07/31/2024
• Device Model Number: 5532-T-214Y
• Device Catalogue Number: 5532-T-214Y
• Device Lot Number: A1QCW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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