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

Model Number N/A

Device Problems Biocompatibility (2886); Activation, Positioning or Separation Problem (2906)

Patient Problems Discomfort (2330); Unequal Limb Length (4534); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product.Bonemaster ltd acet shl 50d; catalog no#: 010000702; lot#: 6826595.G7 dual mobility liner 40mm d; catalog no#: 110024462; lot#: 781360.Act artic e1 hip brg 28x40mm s46 dia28; catalog no#: ep-200146; lot#: 789530.Femoral head sterile product do not resterilize 12/14 taper; catalog no#: 00-8018-028-02; lot#: 64608278.Therapy date: (b)(6) 2020.The manufacturer did receive per, stickers and x-ray for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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 Description

Patient was implanted on the right side and underwent revision surgery due to long on exam and uncomfortable.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient underwent a hip arthroplasty on (b)(6) 2020 which was revised on (b)(6) 2020 as the patient felt uncomfortable due to limb length discrepancy.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: single ap film of the right hip recorded on (b)(6) 2020 demonstrates a right total hip arthroplasty.Femoral stem is incompletely evaluated.Overall fit in alignment of the implants is appropriate.Acetabular inclination angle cannot be accurately measured without a true ap pelvis film.However, visually, the acetabular cup appears to be in appropriate position.The surgical reports are not available due to privacy legislation.Patient data: s.Y., female, born (b)(6) 1955, 163 cm, 77 kg, bmi: 29.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 was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was not approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.For all 39 parts from lot number 2924231, the dimensions defined in the inspection plan were inspected with the 3d measuring machine.All dimensions were according to specifications.Conclusion: it was reported that the patient underwent a hip arthroplasty on (b)(6) 2020 which was revised on (b)(6) 2020 as the patient felt uncomfortable due to limb length discrepancy.No product was returned; therefore, visual and dimensional evaluation could not be performed.One radiograph was provided and reviewed by a health care professional.It shows a recent placement of a right total hip arthroplasty with incomplete visualization of the femoral stem.Visually, the acetabular inclination angle is within normal limits although cannot be measured as the pelvis is not completely imaged on the study.No further evaluation could be performed with the provided radiograph image.No additional medical records were provided.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).Based on the provided event description, the most likely root cause is procedure-related.Nevertheless, based on the given information, the reported leg length discrepancy cannot be confirmed and therefore a definitive root cause could not be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: AVENIR STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14
• Type of Device: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11088122
• MDR Text Key: 224533967
• Report Number: 0009613350-2020-00622
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024590977
• UDI-Public: 00889024590977
• Combination Product (y/n): N
• PMA/PMN Number: K123392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.004
• Device Lot Number: 2924231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 77