MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 10/18/2013

Event Type  Injury  

Manufacturer Narrative

(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 ¿results of 30 reverse shoulder prostheses for revision of failed hemi- or total shoulder arthroplasty¿ by phillippe valenti; alexandre sahin killnc; phillippe sauzieres; and denis katz; published in eur j orthop surg tramatol online on october 18, 2013, was reviewed.The article¿s purpose was to report on a retrospective study to evaluate the clinical and radiological outcomes of a series of 30 reverse shoulder prosthesis performed as revision of failed hemi- or total shoulder arthroplasty.There were a total of 14 delta iii reverse prosthesis used and 16 competitor prosthesis used.The delta iii was fixed with cement.The type or brand of cement was not noted within the article.The article reports the differences in constant-murley scores, however did not associate the complications with the type of prosthesis.There were complications noted of: dislocations (one inferior and one humeral loosening with deep infection that was re-operated on), deltoid palsey, and material disassembly (disassociation).There were also notes of scapular notching in four cases based on radiographic findings.No revisions of the delta iii due to glenoid loosening.

Manufacturer Narrative

Product complaint (b)(4).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.H10 additional narrative: 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.Investigation methods: was patient affected: yes.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: no.Product checked: no.Label checked: no.Product pulled from stock for inspection: no a review of complaint databases was not possible as no product details were received.It should be noted that no device was returned.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9293996
• MDR Text Key: 184898612
• Report Number: 1818910-2019-114968
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• 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: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention