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It was reported that left hip revision surgery was performed due to pain.Elevated test results for cobalt were obtained.As of today, device return and additional information has been requested for this complaint but has not become available.Using the supplied implantation dates, hospital name and implanting surgeon¿s name, the devices part numbers involved in this case have been preliminarily identified (subject to confirmation with medical records).The devices identified were as follows: device 1 74122154 bhr cup hap, lot 10110.Device 2 74122548 hemi head, lot 07hw13135 sap.Device 3 74222200 modular sleeve, lot 08gw17832.Device 4 71306113 syn stem, lot 08gm20516a.In the absence of the actual devices, the production records were reviewed for these devices believed to be involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.Initially the patient was satisfied but developed pain approximately 1 year before the revision and 9 year after implantation.Patient reported elevated blood cobalt concentrations approximately 9 months before the revision and 2 weeks before the revision (3.6 ¿g/l and 6.4 ¿g/l, reference < 1.0 ¿g/l).Without additional medical documentation on the symptoms, surgical reports and x-rays further investigation cannot be performed and factors that might have negatively influenced the implant survival cannot be ruled out or identified.Without the device available for analysis, a relation to possible increased amounts of wear or material loss from the taper cannot be assessed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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