MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COCR RESURFACING HEAD PRESS FIT SIZE 50/20.00MM-STERILE; PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5555-50/20

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

Implanted approximately four (4) and half years ago ((b)(6) 2014).Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: patient reported complaint: it was reported that approximately four (4) and half years ago ((b)(6) 2014), a patient underwent an unknown procedure to treat a shoulder fracture and was implanted with a glenoid epoca, head epoca and articular ligament.This procedure followed osteoarthritis that reached to the patient¿s shoulder.The patient had recurrent dislocation and pain.His shoulder creaks and squeaks during movements and recent radiology reports shows that the prosthesis was worn.In 1965, the patient had a serious accident that resulted a fracture of the humerus and luxation of the shoulder.During this time, putting a cast for compression or other means of consolidation was impossible.Instead, a large heavy plaster was put in place which required the patient to be in, most often possible, standing position, so that the weight keeps the bone as straight as possible.However, this only aggravated the dislocation in the patient¿s shoulder and made it recurrent.In one of the patient¿s visits to a physiotherapist, it was found out that during movements, the humeral head partially came out of its receptacle.This was felt by the physiotherapist during manipulation.The patient had always had more or less pain, which was tendinous or muscular.For a about a year, things had gotten worse, and now the damage is almost permanent, which even annoyed the patient to drive.The patient¿s shoulder creaks and squeaks during movements.A recent radiology report revealed a worn prosthesis.The patient was asking if it was normal for the prosthesis to get worn after four (4) years that it was implanted.This report is for one (1) cocr resurfacing head press fit size 50/20.00mm-sterile.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: update: patient report : " dr (b)(6), a shoulder and knee specialist, who operated on patient's knee, looked at the x ray on the shoulder.The doctor suggested that maybe there is a normal wear of the prosthesis.Dr (b)(6) scheduled a left shoulder scan ( research if there is a normal wear of the glenoid prosthesis).Dr (b)(6) recommended to schedule a rendezvous with dr (b)(6) with the scan.Patient is scheduled to see dr (b)(6) in mid-(b)(6).The patient shoulder sometimes cracks.And hurts, not at rest but during the movement ".

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Patient's height reported as: 173cms.H4, h6: without a valid lot number the device history records review could not be completed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was further reported that it was reported that initially on (b)(6) 2014 the patient underwent a total arthroplasty of the left shoulder to treat a fracture and was implanted with a glenoid epoca, head epoca and articular ligament.Scan was reviewed by surgeon on (b)(6) 2019.Surgeon noted that glenoid part fracture of the prosthesis was probably occurred during the bicycle accident.A fracture of the clavicle opposed to the prosthesis occurred following this accident.So, the impact between the metallic part and the glenoid part caused the fracture of the implant.Surgeon stated it is necessary to change the prosthesis.

• Brand Name: COCR RESURFACING HEAD PRESS FIT SIZE 50/20.00MM-STERILE
• Type of Device: PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8668837
• MDR Text Key: 147031045
• Report Number: 8030965-2019-64907
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 07611819950795
• UDI-Public: (01)07611819950795
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5555-50/20
• Device Lot Number: 3113408
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85