MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled ¿long-term survivorship and clinical and radiological follow-up of the primary uncemented delta iii reverse shoulder prosthesis¿ written by johannes h.M.Van ochten et al, published in the journal of orthopaedics on march 24, 2019, was reviewed.The purpose of the study was to evaluate the long-term survivorship and results of the primary implanted delta iii rtsa utilizing uncemented humeral stems.Depuy products used: delta iii reverse total shoulder arthroplasty.From 2001 until 2006, a consecutive series of 61 rtsas in 60 patients were recruited for the study.Out of those, a total of 27 had complete clinical follow-up.10 of the patients were visited at home and therefore did not have follow-up radiographs.Adverse events are as follows: in five of the 61 prostheses, the rtsa was revised.In one patient, the base plate, glenosphere and inlay were exchanged because of loosening after a fall on the shoulder.In one patient the rtsa was converted to a hemiarthroplasty because of persistent pain in the affected shoulder.In two patients, a humeral neck lengthener was implanted, and the insert was exchanged due to instability of the rtsa.In only one patient the uncemented humeral stem was revised in combination with cerclage, because of periprosthetic fracture.In all 61 rtsa¿s, seven complications not needing revision in six patients were chart documented.In one patient, a postoperative fracture of the acromion was fixated.Unfortunately, this patient developed a pseudarthrosis and had to be operated (scapular plate fixation) once more.In one patient, an intraoperative glenoid fracture occurred, which was treated with a small plate intraoperatively.One patient suffered a periprosthetic humeral fracture after a fall, which was treated conservatively.Three patients needed fixation of the acromion due to a non-union of the osteotomy.17 shoulders had radiological review.No lucent lines of the stem were seen in 11 patients.Loosening less than 2-mm in zone 1 was seen in one patient.Loosening greater than 2-mm in zone 1 was seen in two patients, in two other patients stress shielding of bone was seen in zone 7.In one patient loosening of the distal screw of the baseplate was observed.Scapular notching was observed in two patients, grade 3 in two patients, grade 2 in six patients, grade 1 in six patients, and no scapular notching in one patient.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 9595672
• MDR Text Key: 189222615
• Report Number: 1818910-2020-01948
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1