MAUDE Adverse Event Report: ZIMMER, INC. UNK ZIMMER KNEE; KNEE PROTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

It is reported that the pt is experiencing falls.The pt reports having to use a cane and wear a knee brace.

Manufacturer Narrative

Evaluation summary: operative notes were not provided.Radiographs were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Attempts have been made to obtain additional info; however, no info has been received to date.A definitive root cause cannot be determined with the info provided.However, the complaint may be revised upon return of radiographs and/or product or further info.Evaluation codes: the part and lot numbers are unk; therefore, device history records could not be reviewed and compatibility could not be verified.No device or photos were provided; therefore, the condition of the components is unk.

• Brand Name: UNK ZIMMER KNEE
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4203702
• MDR Text Key: 4962218
• Report Number: 1822565-2014-01434
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2014
• 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): Other
• Patient Weight: 68