MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CLS SPORTORNO CUP; HIP PROSTHESIS

Model Number N/A

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

This event is part of a journal article: long-term results of total hip arthroplasty performed using a cementless expansive acetabular cup and spotorno femoral stem.The aim of the study was to investigate the long-term clinical and radiological results, revision rates and causes, and the rate of implant survival in total hip arthroplasty performed using cls expansion cup and spotorno cementless femoral stem.114 patients participated in the study out of which 39 were males and 75 were females.8 patients underwent revision surgery due to fracture of the cls spotorno cup.

Event Description

Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Investigation and conclusion: multiple clinical events are described in the article long-term results of total hip arthroplasty performed using a cementless expansive acetabular cup and spotorno femoral stem [1], which was published in the pakistan journal of medical sciences on 09-nov-2021.Harm: s3 - instability, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively.Clinical results of total hip arthroplasty performed on 131 hips of 114 patients in istanbul training and research hospital between 1993 and 2003 were retrospectively evaluated according to the harris hip score.Results: revision surgery was performed on 12 hips (9.2%): - broken shell of the cup in four cases - aseptic loosening in three cases - polyethylene wear in three cases - late periprosthetic infection in one case - late dislocation that included polyethylene wear and aseptic loosening in one hip femoral stem revision was performed in 3 hips: - two patients experienced aseptic loosening - one patient had an infection the mean acetabular cup angle of the patients who underwent revision surgery was 53.0 plus/minus 9.5 at the final follow-up.In four patients with broken cup wings, the mean acetabular cup angle was 55.75 plus/minus 6.45 at the final follow-up.Various complications that did not require a revision surgery were detected in 21 patients: - dislocation developed in three patients within the first month after surgery.It was noticed that these patients were followed up with hip abduction orthosis for three weeks after closed reduction, and they did not have any stability problems afterwards.- three patients that developed deep vein thrombosis, diagnosed by clinical examination and doppler ultrasonography, recovered with medical treatment.- femoral fractures developed during the placement of the femoral component in five patients, one of which was in the greater trochanter.Fractures were fixed with cerclage wiring.The prostheses in these patients were found to be stable at the final follow-up.- superficial wound infection in six patients and deep wound infection in another one were taken under control with antibiotics and wound debridements.One late deep periprosthetic infection underwent revision surgery.- two patients were observed to develop foot drop due to sciatic nerve damage in the postoperative period.One of these patients fully recovered at the 3rd and the other at the 6th month, after being followed up with ankle-foot orthoses patient involved.Because no medical records are available for the individual cases described in the article, it was not possible to evaluate the individual reported events in detail.As no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer switzerland manufacturing gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer switzerland manufacturing gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.[1] carkci e, polat ae, ozturkmen y, tuzuner t.Long-term results of total hip arthroplasty performed using a cementless expansive acetabular cup and spotorno femoral stem.Pak j med sci.2021;37(1):52-58.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.(b)(4).The following reports are associated with this event: 0009613350-2021-00507-1.

• Brand Name: CLS SPORTORNO CUP
• Type of Device: HIP PROSTHESIS
• 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: 12518757
• MDR Text Key: 272890592
• Report Number: 0009613350-2021-00490
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention