MAUDE Adverse Event Report: TORNIER INC UNKNOWN_WRIGHT TORNIER-BLOOMINGTON_PRODUCT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTB

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported that the patient had a superficial infection.The patient was treated with irrigation and debridement with saline and vancomycin powder.All the hardware was left in the patient as the doctor deemed the infection was not deep enough to have been a result of the implants.

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient. a review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

Please disregard the report linked to mfr # 0001649390-2023-00047, additional information was received indicating that the alleged deep infection involves (7) stryker devices not (8) which were successfully reported under the following numbers: mfr # 0001649390-2023-00152, mfr # 0001649390-2023-00153, mfr # 0001649390-2023-00154, mfr # 0001649390-2023-00155, mfr # 3000931034-2023-00205, mfr # 0001649390-2023-00156 and mfr # 0001649390-2023-00157.And therefore mfr# 0001649390-2023-00047 will be officially cancelled out in our system.

Event Description

It was reported that the patient presented with superficial infection.The physician treated the infection with irrigation and debridement with saline and vancomycin powder.All the hardware was left in the patient as the doctor deemed the infection was not deep enough to have been a result of the implants.The patient was administered and prescribed antibiotics.

• Brand Name: UNKNOWN_WRIGHT TORNIER-BLOOMINGTON_PRODUCT
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16728173
• MDR Text Key: 313170377
• Report Number: 0001649390-2023-00047
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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