MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER KNEE REPLACEMENT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 12/21/2020

Event Type  Injury  

Event Description

I had right knee replacement, zimmer product was used.The whole year i experienced pain, swelling, had to be drained, injections.At times couldn't work, multiple issues.Regular x-rays didn't show anything.Was scheduled for a special bone scan right before my year anniversary.It was found that the implant had loosened and separating.I'm now facing a second surgery in march 1 for a revision.I feel it's important to check this company.I should never have had to have this much trouble.Fda safety report id# (b)(4).

Event Description

I had right knee replacement, zimmer product was used.The whole year i experienced pain, swelling, had to be drained, injections.At times couldn't work, multiple issues.Regular x-rays didn't show anything.Was scheduled for a special bone scan right before my year anniversary.It was found that the implant had loosened and separating.I'm now facing a second surgery in march 1 for a revision.I feel it's important to check this company.I should never have had to have this much trouble.Fda safety report id# (b)(4).

• Brand Name: ZIMMER KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 13584402
• MDR Text Key: 286109181
• Report Number: MW5107631
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White