MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown epoca system.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

This report is being filed after the subsequent review of the following literature article: thangarajah t.(2017).Anatomical shoulder arthroplasty in epileptic patients with instability arthropathy and persistent seizures.Journal of orthopaedic surgery, volume 25(2), pages 1-6.United kingdom.The purpose of this study was to report the results, complications and rate of revision surgery following anatomical shoulder arthroplasty in epileptic patients with instability arthropathy.Between november 1996 and july 2013, 179 patients with epilepsy underwent shoulder surgery.All epileptic patients in whom shoulder arthroplasty had been performed for instability arthropathy were included in this study of these, 8 shoulders in 8 consecutive patients underwent anatomical arthroplasty for instability arthropathy.These included 3 total shoulder replacements (tsr) and 5 humeral head resurfacing hemiarthroplasty (hhrh) procedures.The mean duration of epilepsy in the cohort was 12 years (range, 4¿19) and all patients suffered from grandmal seizures.Primary dislocation occurred a mean of 13 years (range, 4¿22) before surgery.The mean age at the time of surgery was 33 years (range, 17¿44).The cohort consisted of 7 males and 1 female patient.6 patients had anterior instability and 2 had posterior instability.1 patient had bilateral symptoms.Arthroplasty was performed after an average of 2 previous stabilization procedures (range, 0¿3) in all but 2 patients in whom the procedure was used as primary treatment due to extensive degenerative changes (patient 3 and 8).Implants used for total shoulder arthroplasty (tsa) included: 1 customized prosthesis (stanmore implants, (b)(4)) and 2 epoca humeral components (depuy- synthes, (b)(4)) with metal-backed glenoids.The hhrh implants comprised: 2 eclipse humeral resurfacing components (arthrex, (b)(4)), 1 customized humeral resurfacing replacement (stanmore implants, (b)(4)), 1 epoca humeral resurfacing component (synthes, (b)(4)) and 1 tess humeral resurfacing component (biomet, (b)(4)).Mean follow-up was 4.7 years (range, 2¿7.5 years).Following surgery, all patients continued to have grand mal seizures but none had any further episodes of instability/dislocation.All patients were evaluated using plain radiographs (anteroposterior and axillary views) and computed tomography (ct) scan to quantify bone loss.Post-operatively, all radiographs were reviewed for the presence of periprosthetic lucency and alteration in the position of the components.Radiographs for patients who underwent hemiarthroplasty were additionally examined for glenoid erosion.Glenoid erosion was graded as none, mild if there was erosion into subchondral bone, moderate if there was medialization of the glenoid subchondral bone with associated hemispheric deformation of the glenoid or severe, if there was complete hemispheric deformation of the glenoid with bone loss to the base of the coracoid.Component migration was defined as present or absent.Pre-operative and post-operative clinical outcome measures included active forward elevation and active external rotation.The oxford shoulder score (oss) was used to assess function.18 in addition, all patients were evaluated using the subjective shoulder value (ssv), which uses a scale from 0 (worst score) to 100 (best score) to describe the affected shoulder.19 this can be used as a supplementary tool to traditional, more complex outcome measures and may be used in conjunction with otherscores to assess the patients¿ outcome.Patient 1 ¿ (b)(6) female patient underwent humeral head resurfacing hemiarthroplasty (hhrh) procedure.Patient was implanted with 2 eclipse humeral resurfacing components (arthrex, (b)(4)), 1 customized humeral resurfacing replacement (stanmore implants, (b)(4)), 1 epoca humeral resurfacing component (synthes, (b)(4)) and 1 tess humeral resurfacing component (biomet, (b)(4)).Patient was followed up for 2 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation.Patient required revision to an epoca (depuysynthes, (b)(4)) total shoulder replacements (tsr) with a metal backed glenoid at 1.2 years due to persistent pain from ongoing glenoid arthritis.Patient had evidence of glenoid erosion.Patient 2 ¿ (b)(6) male patient underwent humeral head resurfacing hemiarthroplasty (hhrh) procedure.Patient was implanted with 2 eclipse humeral resurfacing components (arthrex, (b)(4)), 1 customized humeral resurfacing replacement (stanmore implants, (b)(4)), 1 epoca humeral resurfacing component (synthes, (b)(4)) and 1 tess humeral resurfacing component (biomet, (b)(4)).Patient was followed up for 4.4 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation.Patient had evidence of glenoid erosion.Patient 3 ¿ (b)(6) male patient underwent humeral head resurfacing hemiarthroplasty (hhrh) procedure.Patient was implanted with 2 eclipse humeral resurfacing components (arthrex, (b)(4)), 1 customized humeral resurfacing replacement (stanmore implants, (b)(4)), 1 epoca humeral resurfacing component (synthes, (b)(4)) and 1 tess humeral resurfacing component (biomet, (b)(4)).Patient was followed up for 3.1 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation.Patient had evidence of glenoid erosion.Patient 4 ¿ (b)(6) male patient underwent humeral head resurfacing hemiarthroplasty (hhrh) procedure.Patient was implanted with 2 eclipse humeral resurfacing components (arthrex, (b)(4)), 1 customized humeral resurfacing replacement (stanmore implants, (b)(4)), 1 epoca humeral resurfacing component (synthes, (b)(4)) and 1 tess humeral resurfacing component (biomet, (b)(4)).Patient was followed up for 6 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation.Patient developed painful glenoid arthritis and was treated with an epoca (depuy- synthes, (b)(4)) metal-backed glenoid replacement at 1.8 years.Patient had evidence of glenoid erosion.Patient 5 ¿ (b)(6) male patient underwent humeral head resurfacing hemiarthroplasty (hhrh) procedure.Patient was implanted with 2 eclipse humeral resurfacing components (arthrex, (b)(4)), 1 customized humeral resurfacing replacement (stanmore implants, (b)(4)), 1 epoca humeral resurfacing component (synthes, (b)(4)) and 1 tess humeral resurfacing component (biomet, (b)(4)).Patient was followed up for 4.6 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation.Patient had evidence of glenoid erosion.Patient 6 ¿ (b)(6) male patient underwent total shoulder replacements (tsr) procedure.1 customized prosthesis (stanmore implants, (b)(4)) and 2 epoca humeral components (depuy- synthes, (b)(4)) with metal-backed glenoids).Patient was followed up for 4.6 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation patient 7 ¿ (b)(6) male patient underwent total shoulder replacements (tsr) procedure.1 customized prosthesis (stanmore implants, (b)(4)) and 2 epoca humeral components (depuy- synthes, (b)(4)) with metal-backed glenoids).Patient was followed up for 7.5 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation patient 8 ¿ (b)(6) male patient underwent total shoulder replacements (tsr) procedure.1 customized prosthesis (stanmore implants, (b)(4)) and 2 epoca humeral components (depuy- synthes, (b)(4)) with metal-backed glenoids).Patient was followed up for 5.3 years.Following surgery, patient continued to have grand mal seizures but did not have any further episodes of instability/dislocation 3 patients had severe degenerative changes.It is unknown if this patient underwent total shoulder replacements (tsr) or humeral head resurfacing hemiarthroplasty (hhrh) procedure 1 patient had moderate degenerative changes.It is unknown if this patient underwent total shoulder replacements (tsr) or humeral head resurfacing hemiarthroplasty (hhrh) procedure 4 patients had mild degenerative changes.It is unknown if this patient underwent total shoulder replacements (tsr) or humeral head resurfacing hemiarthroplasty (hhrh) procedure 1 patient with humeral head resurfacing hemiarthroplasty (hhrh) developed painful glenoid arthritis.This report is for unknown epoca humeral components (depuy- synthes (b)(4)) and epoca humeral resurfacing component (synthes (b)(4)) a copy of the literature article is being submitted with this medwatch.This report is for 3 patients who had severe degenerative changes, 1 patient who had moderate degenerative changes, and 4 patients who had mild degenerative changes.This is report 6 of 7 for complaint (b)(4).

• Type of Device: PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7374219
• MDR Text Key: 103663129
• Report Number: 8030965-2018-52471
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention