MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND RETENT PE CUP D38 +6MM; SHOULDER HUMERAL CUP

Catalog Number	130738106
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Primary (b)(6) 2017, revision (b)(6) 2017, revision (b)(6) 2017, revision (b)(6) 2017.Recurrent dislocation post rtsjr.This is the third revision of this joint replacement.Second revision included use of a retentive spacer.There was no issue with version of the cemented stem in situ (as per surgeon).This was left in situ and the liner and glenosphere were upsized.It was suggested that the dislocations were possibly anterior.The surgeon positioned an eccentric glenoshere more anteriorally despite being informed they were not meant to be used in this way and a trial would not be possible.The shoulder was reduced successfully and the surgeon reported stability by the finish of the procedure.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the device associated to the complaint was not returned for analysis.The dhr analysis performed did not reveal any anomalies that could be related to the issue reported on the complaint.A search into the complaints database was performed, no other similar complaint was reported for the affected product code and lot combination.Based on the information received and the investigation performed, the root cause of the incident could not be determined.Device history lot :the dhr analysis of the stem batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.Batch 5217451 was manufactured in september 2013.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND RETENT PE CUP D38 +6MM
• Common Device Name: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7206483
• Report Number: 1818910-2018-51547
• Device Sequence Number: 19203950
• Product Code: HSD
• UDI-Device Identifier: 10603295027355
• UDI-Public: 10603295027355
• Combination Product (Y/N): N
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 130738106
• Device Lot Number: 5217451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention