VANGUARD PFR FEMORAL LT SM
Received May 17, 2018
Report 0009610576-2018-00017 · MDR key 7521358
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet Spain, S.l.Model number
N/ACatalog number
11-150908
Lot number
2014040696
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
57 YR
- Arthritis
- Pain
- Swelling
- Ambulation or Postural Difficulties
- Arthritis
- Pain
- Swelling
- Ambulation or Postural Difficulties
Narrative
Additional Manufacturer Narrative
(B)(4). EVENT DATE UNKNOWN. IMPLANT SURGERY WAS (B)(6) 2015. CONCOMITANT MEDICAL PRODUCTS: P/N 184784, LOT 608490. P/N 00-1112-140-01, LOT 80424395. PATIENT REPORTS ALLERGY (BUT NOT CONFIRMED). REF. (B)(4). VANGUARD PFR FEMORAL LT SM WAS CLEARED IN THE U.S. UNDER 510(K) K000827, FDA PRODUCT CODE KRR. THIS EVENT WAS PREVIOUSLY REPORTED BY THE PATIENT UNDER MW5076326. PRODUCT REMAINS IMPLANTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONTINUOUSLY WITH PAIN, SWELLING AND STIFFNESS.