Medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01.
00185.
145; lot#: unknown.
Metasul ldh, head, 46, code l, taper 18/20; catalog#: 01.
00181.
460; lot#: unknown.
Therapy date: unknown.
The manufacturer did not receive devices, x-rays, or other source documents for review, as the patient is currently being monitored and has not been revised to date.
As no lot numbers were provided for the devices, the device history records could not be reviewed.
The cause for this specific event cannot be ascertained from the information provided, as the patient has not been revised.
The common clinical presentation and the date of the original implantation suggest that this case might be related to the issues for which zimmer implemented a notification in july 2008 as referenced.
Should additional information become available and / or the device(s) be returned for evaluation and an investigation result is available, an amended medical device report will be submitted.
Zimmer¿s reference number of this file is (b)(4).
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