MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 5, TAPER 12/14; AVENIR MULLER STEM

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products and therapy date, detail of product: item number 010000664, item name g7 pps ltd acet shell 54f, lot # 6536075.Item number 010000858, item name g7 neutral e1 liner 36mm f, lot # 6524746.Item number 00877503602, item name biolox delta, ceramic femoral head, m, 36/0, taper 12/14, lot # 2994017.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation as the patient has not been revised.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.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
It was reported that patient had an initial implant and subsequently was noted to have stem subsidence.Patient is under observation, unknown if any intervention will take place.
Event or Problem Description
Please refer to report 0009613350-2019-00650.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Trend analysis: no trend has been identified.Event description: it was reported that the patient (id: (b)(6)), taking part in the mymobility clinical study, had an initial implant surgery on (b)(6) 2019.Subsequently, on (b)(6) 2019 patient was noted to have stem subsidence.Patient is under observation, no intervention provided at this time.Review of received data: clinical study protocol for patient (b)(6): tha was performed on the left side on (b)(6) 2019.Adverse event, dated (b)(6) 2019, hip stem subsidence.Medical records were reviewed: female patient, 74 years of age, bmi: 30.95.Surgical history: carpal tunnel (left and right), rotator cuff repair, arthroscopic shoulder (left), htep (right), ktep (left), arthroscopic knee (right), hand (bilateral), tonsillectomy, sinus, tubal ligation.Examination, (b)(6) 2019: patient is 1/4 to 3/8 inch short on the left side.She has an antalgic gait.Left hip rom 0 to 110°.Pain when abduction is beyond 20°, when external or extreme internal motion beyond 20°.She has adduction of about 10°.X-rays: show severe end-stage arthritis of her left hip with complete loss of all her joint spaces, cam and femoroacetabular impingement, protrusio.Her right hip has a tapered stem.No sign of poly wear or osteolysis with good cup position.Impression: severe end-stage arthritis, left hip, end-stage arthritis of her right knee.She is status post left total knee replacement and right total hip replacement.The patient has failed medical management and has decreased activities of daily living.She is unable to participate in the activities once enjoyed.The patient is limping and has night pain.Plan: left total hip replacement.Surgical report, (b)(6) 2019: i removed the avenir broach and inserted a 5 lateral avenir stem.When i impacted the femoral head onto the stem, a slight small crack was noticed on the inferior medial part of the calcar, so i removed the head and stem.I placed a cable around the femur and then washed the entire wound with irrisept as well as the stem and reinserted the stem and impacted it again and then reduced the hip.Visit 3 weeks postoperative, (b)(6) 2019: she intraoperatively had a small calcar fracture that was treated with a cerclage cable.She is here today for complaints of groin and thigh pain and difficulty lifting her leg.She is also complaining of left knee pain.She has a history of a left total knee arthroplasty.An ap pelvis and 1 view of the left hip were obtained today.Ap hip center pelvis and crosstable lateral of the left hip reveal bilateral total hip arthroplasties.The left femoral component shows a proximal cerclage cable.The stem appears to have had a very subtle subsidence when compared with the immediate postoperative images.The crosstable lateral view does not reveal any hypodense changes around the implant that would indicate an unstable stem.Ap lateral and merchant view of the left knee reveals a cemented left total knee arthroplasty to be in stable position with the patella tracking well through the notch.There is severe right knee patellofemoral degeneration.In total 4 x-rays have been received for review: two hip overview x-rays, dated (b)(6) 2019: the x-rays are in pdf format and of very low resolution.The x-rays show a left htep and a cerlcage cable at the level of the lesser trochanter.One hip overview and one second view x-ray, dated (b)(6) 2019: the x-rays are in pdf format and of low resolution.The x-rays show a left htep and a cerlcage cable from the top of the lesser trochanter below the greater trochanter.Device analysis: no product was returned to zimmer biomet for in-depth analysis, as the stem remains implanted.Review of product documentation: this device is intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The three diameters of the stem, important to the primary stability of the stem, were inspected with 3d measuring machine in all 39 parts of lot 2986301 and found to be conforming to the defined standards.Conclusion: it was reported that the patient (id: (b)(6)), taking part in the mymobility clinical study, had an initial implant surgery on (b)(6) 2019.Subsequently, on (b)(6) 2019 patient was noted to have stem subsidence.Patient is under observation; no intervention has been performed at this point.Due to the very low resolution of the provided x-rays no evaluation of a potential stem subsidence could be performed.The medical notes of the postoperative visit at 3 weeks' state that the stem appears to have had a very subtle subsidence when compared with the immediate postoperative images.The stem remains implanted, therefore visual and dimensional evaluation could not be performed.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).In conclusion, based on the medical documentation it can be assumed that a very subtle stem subsidence occurred, however due to the lack of a complete x-ray follow-up with high resolution, we were neither able to recreate the reported stem subsidence nor to identify an exact root cause for the reported event.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).

• Brand Name: AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 5, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9278370
• Report Number: 0009613350-2019-00650
• Device Sequence Number: 345432
• Product Code: LZO
• UDI-Device Identifier: 00889024479524
• UDI-Public: 00889024479524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.105
• Device Lot Number: 2986301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 03/31/2020
• 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: Other
• Patient Weight: 88