MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#7 9MM; IMPLANT

Catalog Number 5530G709

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 09/19/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Patient's cat scratched him 2 months post op.Patient acquired pasteurella from this scratch.Dr.(b)(6) removed the liner and performed a debridement and liner exchange.

Manufacturer Narrative

The following devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-339; lot# h62y, triathlon cr fem comp #6 l-cem; cat# 5510-f-601; lot# empjp, triathlon prim cem fxd bplt #7; cat# 5520-b-700; lot# aar4c.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.When completed, the evaluation summary will be submitted in a supplemental report.An event regarding infection involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection of a photograph of the reported device provided shows that the insert had been implanted and is unremarkable.No other inspection was possible as the device was not returned.-medical records received and evaluation: medical review indicated that in this case no correlation between any specific device property and infection can be established.Patient had bad luck to sustain an infectious complication of the knee arthroplasty after a cat¿s scratch that progressed to an arthroplasty infection where the animal source of the infection has been established with certainty due to the pasteurella nature of the bacteria involved.Early intervention was adequate although there is no info on further outcome or whether infection is really under control.As such, this pi case is not device-related but has its root cause in an adverse patient-related factor.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: there have been no other events for the reported lot or sterile lot.Conclusions: the patient was scratched by a cat postoperatively.The medical review completed indicates that the cat¿s scratch progressed to an arthroplasty infection through lymphatic pathways where the animal origin of the infection has been established with certainty due to the pasteurella nature of the bacterial species involved.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient's cat scratched him 2 months post op.Patient acquired pasteurella from this scratch.Dr.(b)(6) removed the liner and performed a debridement and liner exchange.

• Brand Name: X3 TRIATHLON INSERT CR#7 9MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick 00000
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5147324
• MDR Text Key: 28140230
• Report Number: 0002249697-2015-03377
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 5530G709
• Device Lot Number: LDE011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2013
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 113