Zimmer, Inc.

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.