MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14; AVENIR MULLER STEM

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.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.(b)(4).
Event or Problem Description
During the surgery the head could not be detached from the shaft.It is not known if there was a delay in surgery.
Additional Manufacturer Narrative
Review of event description: during surgery on (b)(6) 2020, the head could not be detached from the shaft.Product evaluation: visual examination: the avenir stem with mounted cocr head was returned for examination.The head is firmly mounted on the stem and could not be removed.The lot marking of the stem is on the stem taper and is therefore not accessible.There are some scratches on the head.There are also some fine scratches on the stem.In addition, some parts of the hydroxyapatite coating are worn.Measurements: measurements were not taken, as the head could not be disassembled from the stem.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records of the cocr head identified no deviations or anomalies during manufacturing.Due to unknown lot number of the stem, the stem's dhr could not be reviewed.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: during surgery on (b)(6) 2020, the head could not be detached from the shaft.Based on the investigation the reported event can be confirmed.The head cannot be removed from the stem taper.The investigation did not identify a nonconformance or a complaint out of box (coob).It is possible that too much force was applied during head assembly, or that the taper surfaces of the head and/or the stem were not properly cleaned prior to impaction.Nevertheless, an exact root cause could not be found.The need for corrective measures is not indicated and zimmer (b)(4) manufacturing (b)(4) considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.Investigation results are now available.

• Brand Name: AVENIR MLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11154726
• Report Number: 0009613350-2021-00008
• Device Sequence Number: 14020807
• Product Code: LZO
• UDI-Device Identifier: 00889024590977
• UDI-Public: 00889024590977
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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