MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN ALLOCLASSIC STEM CEMENTLESS; HIP PROSTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930)

Event Date 10/20/2020

Event Type  Injury  

Event Description

It was reported in a journal article that a randomized study comparing metal-on-metal (metasul) and ceramic-on-ceramic (cerasul) bearings was conducted.The present report covers the cerasul group which consisted of 125 thas in a total of 115 patients.At a mean 18-year follow-up, there were six clinical failures in the cerasul group: four ceramic insert fractures (at 6, 13, 14, and 17 years).Revised successfully by one-stage exchange.One late deep infection (at 10 years) which was successfully treated with 2-stage revision.One periprosthetic fracture (at 17 years).No further information is available.

Manufacturer Narrative

The described events are part of a study comparing metal-on-metal (metasul) and ceramic-on-ceramic (cerasul) bearings.A prospective, randomized study was originally performed on a consecutive series of 250 cementless primary total hip arthroplasties between 1999 and 2002.For each bearing (metasul or cerasul), 125 that were initially included.They all received a cementless alloclassic® stem (sulzer, switzerland) and allofit® cup (sulzer, switzerland) with a 28-mm head.Only the bearing couples were different, either a mom metasul® (sulzer, switzerland) or a coc cerasul® (sulzer, switzerland) was used.Ceramic head and insert were a third-generation biolox forte® alumina (ceramtec, plochingen, germany).All cases were evaluated both clinically and radiographically, and survival was assessed, considering revisions for aseptic loosening or for any reason as the end points for failure.A randomized study was conducted at 9 years and at a mean 18-year follow-up.The present complaint records the events that are related to the cerasul bearings.Harm: s3 - instability, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively.Study results: the cerasul group consisted of 125 thas in a total of 115 patients.At 18-year follow-up, there were six clinical failures in the cerasul group: four ceramic insert fractures (at 6, 13, 14, and 17 years).Revised successfully by one-stage exchange.One late deep infection (at 10 years) which was successfully treated with 2-stage revision.One periprosthetic fracture (at 17 years).Clinical assessment showed radiolucencies around the femoral stems in gruen zones 1 and 7, which is a common occurrence with alloclassic stems.Only 3.5% of osteolysis in cerasul group were found around the cup in all cases.Because no medical records are available for the reported 6 revisions described in these articles, 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.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).The following reports are associated with this event: 0009613350-2021-00394, 0009613350-2021-00670, 0009613350-2021-00672.References: desmarchelier r, viste a, chouteau j, lerat jl, fessy mh.Metasul vs cerasul bearings: a prospective, randomized study at 9 years.J arthroplasty.2013 feb;28(2):296-302.Doi: 10.1016/j.Arth.2012.05.028.Epub 2012 jul 9.Pmid: 22784488.Andeol q, viste a, desmarchelier r, lerat jl, fessy mh.Metasul vs cerasul bearings: a prospective, randomized study at a mean eighteen years.Int orthop.2020 dec;44(12):2545-2551.Doi: 10.1007/s00264-020-04855-9.Epub 2020 oct 20.Pmid: 33083903.

• Brand Name: UNKNOWN ALLOCLASSIC STEM CEMENTLESS
• 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: 13025348
• MDR Text Key: 282492545
• Report Number: 0009613350-2021-00669
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• 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