MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER KNEE DEVICE; KNEE PROSTHESIS

Device Problems Failure To Adhere Or Bond (1031); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It is reported that the pt is experiencing pain, loosening and dislocation.

Manufacturer Narrative

Eval summary: no devices or photos were received; therefore the condition of the components is unk.Surgical notes were not provided.X-rays were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Rehabilitation protocol and adherence thereto is unk.A definitive root cause cannot be determined with the info provided.However, the complaint may be revised upon return of x-rays and/or product or further info.The lot numbers of the devices are unk; therefore the device history records could not be reviewed.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available info, the need for corrective action is not indicated.

• Brand Name: UNKNOWN ZIMMER KNEE DEVICE
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581 ; 8006136131
• MDR Report Key: 4539025
• MDR Text Key: 5358732
• Report Number: 1822565-2015-00219
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/20/2015
• 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: 79