MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FEMORAL HEAD SIZE 28 SHORT

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteolysis (2377)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: fitmore cup; catalog no#: unknown; lot#: unknown.Cement plug size 4; catalog no#: unknown; lot#: unknown.Concomitant medical products - therapy date: (b)(6) 2020.The manufacturer did receive cd with x-rays, surgical report and materiovigilance form 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 Description

Patient was implanted on the left side and underwent revision surgery due to wear and osteolysis.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that a patient underwent a revision surgery on (b)(6) 2020 due to stem loosening.Later it was reported that the indication for revision surgery is pain in the left hip with inlay wear and osteolysis around the stem.It is also mentioned that the stem was not loose.Review of received data: due to circumstances surrounding the covid-19 pandemic, the healthcare facility has indicated that additional information and/or product related to this complaint cannot be provided.Therefore, further due diligence activities will not be performed at this time and the complaint investigation will proceed with currently available information.Should additional information and/or product become available, the complaint investigation will be updated as appropriate.X-rays: no x-rays were received for evaluation.With no x-rays it is not possible to evaluate possible changes to the bone and / or implant position in order to investigate the reported loosening.Six sets of x-rays (pelvis ap and second view of hip) taken between (b)(6) 2005 and (b)(6) 2020 were received for investigation.Three sets of x-rays were taken after the revision surgery on (b)(6) 2019, (b)(6) 2020 and (b)(6) 2020.They do not show the reported components and are therefore not included in this x-ray review.The other three sets of x-rays were taken on (b)(6) 2005, (b)(6) 2018 and (b)(6) 2019.The x-rays taken on (b)(6) 2019 include a peliv overview and a second view of the right hip instead of the left hip and can therefore not be included.The x-rays show different exposure which makes a comparison rather limited.However, when comparing the three pelvis overviews no obvious changes to implant position as well as changes to the bone-cement and cement-implant interfaces can be observed.Surgical report: the surgical report of the revision surgery, dated (b)(6) 2020, states as indication for the surgery: painful hip arthroplasty after 19 years in vivo with pe wear and osteolysis around the stem.Additionally, irritation of the hip abductors.Opening of the joint across the interval between piriformis and gluteus minimus.Trochanteric osteotomy.Dislocation.Removing the exafit.Fixed shell.Removing the inlay.Osteolysis in the area of cementation.Removal of the cement including cement plug.Delivery of tissue samples for bacteriological examination.Delivery of the stem for sonication.Implantation of the new components according to plan.Product evaluation: visual examination: only the stem was received for investigation.Therefore, the inlay wear cannot be evaluated.Under certain light conditions, slight matt areas can be recognized on all sides of the exafit stem.This may indicate a loosening between the implant and the cement.In some small areas signs of corrosion can be recognized.The stem taper also shows signs of corrosion.Revision damage in the form of scratches, nicks and indents can be observed on the stem neck, shoulder and anchoring surface.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that a patient underwent a revision surgery on (b)(6) 2020 due to stem loosening after approximately 19 years in vivo.Later it was reported that the indication for revision surgery is pain in the left hip with inlay wear and osteolysis around the stem.It is also mentioned that the stem was not loose.Based on the surgical report the reported event of osteolysis can be confirmed.Further, the visual examination also indicated possible loosening of the stem.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).In conclusion, the hip endoprosthesis was in vivo for approximately 19 years.Therefore is assumed that the reasons leading to the revision surgery may be multifactorial with contributing factors from the patient and / or the implant.An exact root cause could not be identified for the reported event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation has been completed.

• Brand Name: FEMORAL HEAD SIZE 28 SHORT
• Type of Device: FEMORAL HEAD SIZE 28 SHORT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10710808
• MDR Text Key: 212299367
• Report Number: 0009613350-2020-00494
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2020
• 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