MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR®, STEM, LATERAL, CEMENTED, 6, TAPER 12/14; AVENIR CEMENTED HIP STEM

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a left hip arthroplasty on.Subsequently, the patient was revised due to dislocation.Nobody complaint about the implant.It is believed that the original femoral component was cemented too proud.The patient hip joint was believed to be too tight.It was revised to a smaller size stem and placed with more anteversion.
Additional Manufacturer Narrative
Concomitant medical products: liner 28 mm i.D.For use with 50/51/52 mm o.D.Shells, catalog#: 00500105028; lot#: 64892224.Shell 52 mm o.D.Catalog#: 00500105200 ; lot#: 3039253, femoral head 12/14 taper 28 mm diameter -3.5 neck length catalog#: 802202801; lot#: 3035224.Endo femoral head 12 / 14 taper catalog#: 00781805200 ; lot#: 64808465.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).Product not available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: xray received, implant and revision surgery reports (will be reviewed during investigation).Patient dob: (b)(6) 1944.Patient identifier ((b)(6)).Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00686.
Event or Problem Description
It was reported that patient underwent a left hip arthroplasty on.Subsequently, the patient was revised due to dislocation.Nobody complaint about the implant.It is believed that the original femoral component was cemented too proud.The patient hip joint was believed to be too tight.It was revised to a smaller size stem and placed with more anteversion.
Event or Problem Description
Investigation results are now available.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.Customer indicated that the product is not available.Investigation of this incident has been completed.Event happened in alaska.Investigation and conclusion: 1.Event description: it was reported that the patient underwent left hip hemiarthroplasty on (b)(6), 2021.Subsequently, the patient was revised on (b)(6), 2021 due to recurrent dislocation.It is believed that the original femoral component was cemented too proud and the patient hip joint was believed to be too tight.The stem was revised to a smaller size and placed with more anteversion.Harm: s3 - dislocation.Hazardous situation: implant is implanted with an incorrect orientation, placement or alignment without correction before completing implantation.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: one undated x-ray of the pelvis has been received, but was not reviewed as the revision notes contain sufficient dictation of findings.- surgical report: the surgical report for the initial implantation dated (b)(6), 2021 has been received: indication: closed left displaced femoral neck fracture procedure: open treatment, left femoral neck fracture with hemiarthroplasty.No intraoperative complications were identified.The surgical report for the revision surgery dated (b)(6), 2021 has been received: indication: left unstable hip hemiarthroplasty procedure: left revision hip hemiarthroplasty.No purulence, large hematoma encountered, necrotic devitalized muscle, posterior capsular repair had ruptured: the previously placed hemiarthroplasty was irreducible after remaining out.Retroverted stem corrected into 25 degree anteversion.Patient presented with dislocation, tight adduction contracture noted upon reduction, while inpatient, patient dislocated again while using an abduction pillow and knee immobilizer.Previous stem found to have no anteversion and 3-4 degree retroversion.New stem cemented in place, new head.No intraoperative complications.3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr found.5.Conclusion: it was reported that the patient underwent left hip hemiarthroplasty on (b)(6), 2021.Subsequently, the patient was revised on (b)(6), 2021 due to recurrent dislocation.It is believed that the original femoral component was cemented too proud and the patient hip joint was believed to be too tight.The stem was revised to a smaller size and placed with more anteversion.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Surgical reports provided were reviewed by a health care professional.It was mentioned that the surgeon thought the original femoral component was cemented too proud and the patient's hip joint too tight, leading to a dislocation, but this cannot be confirmed.Therefore, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: AVENIR®, STEM, LATERAL, CEMENTED, 6, TAPER 12/14
• Common Device Name: AVENIR CEMENTED HIP STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13110449
• Report Number: 0009613350-2021-00686
• Device Sequence Number: 11659399
• Product Code: LZO
• UDI-Device Identifier: 00889024590847
• UDI-Public: 00889024590847
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K131884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2022

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.306
• Device Lot Number: 3039253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 03/30/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/28/2022; 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male