MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 16/265, TAPER 12/14; WAGNER SL REVISION STEM LATERAL

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cocr head 28mm +7; catalog#: unknown; lot#: unknown.Luque wires; catalog#: unknown; lot#: unknown.Therapy date: unknown.The manufacturer received other source documents for review.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and is experiencing elevated metal ion levels.Also, the patient is experiencing recurrent falls, progressive cognitive decline with hallucinations.It is unknown if a revision surgery has taken place.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that a female patient underwent a right tha in 2000.In 2013 the patient fell resulting in a periprosthetic fracture of her right femur and underwent revision of her right tha on (b)(6) 2013 receiving a size 16 by 265 mm wagner revision stem.Subsequently, in 2014 the patient is experiencing elevated metal ions (cobalt levels in urine (2.4mcg/l)).Also, the patient is experiencing recurrent falls, progressive cognitive decline with hallucinations.No revision reported.Review of received data: no medical data relevant to the case has been received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification.- dhr review: review of the device history records could not be reviewed due to missing lot number.Conclusion: it was reported that a female patient underwent a right tha in 2000.In 2013 the patient fell resulting in a periprosthetic fracture of her right femur and underwent revision of her right tha on (b)(6) 2013 receiving a size 16 by 265 mm wagner revision stem.Subsequently, in 2014 the patient is experiencing elevated metal ions (cobalt levels in urine (2.4mcg/l)).Also, the patient is experiencing recurrent falls, progressive cognitive decline with hallucinations.No revision reported.Based on missing medical records to attest the reported event the complaint cannot be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Further, based on the significant lack of information and the unavailability of the product(s), we were neither able to confirm nor to identify a specific root cause for the reported issue.
Event or Problem Description
Investigation results are available now.

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED, 16/265, TAPER 12/14
• Common Device Name: WAGNER SL REVISION STEM LATERAL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9848069
• Report Number: 0009613350-2020-00138
• Device Sequence Number: 2896097
• Product Code: LZO
• UDI-Device Identifier: 00889024485211
• UDI-Public: 00889024485211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization