(b)(4).D10 medical devices: nexgen articular surface size ef 10 mm height catalog#: 00596404010, lot#: 63504466 nexgen stemmed nonaugmentable tibial component option cr/ps/lps size 5 catalog#: 00598604701, lot#: 63522901 nexgen all poly patella standard cemented size 32 mm diameter catalog#: 00597206532, lot#: 63530611.G2 foreign source: united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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