It was reported patient underwent a revision procedure ten months post implantation due to pain, swelling, periprosthetic fracture, implant loosening, and infection.Attempts to obtain additional information have been made; however, no more is available.
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(b)(4).D10 - medical product: persona tibia stemmed catalog #: 42532007502, lot #: 65568838.Persona articular surface medial congruent (mc) catalog # 42522100810 lot # 65582241.Bone cement ¿ heraeus catalog #: unk, lot #: 63841131.Bone cement ¿ heraeus catalog #: unk, lot #: 63911134.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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