MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Joint Dislocation (2374); Not Applicable (3189)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

"rotator cuff arthropathy: what functional results can be expected from reverse arthroplasty?", by rodrigo caldonazzo fávaro, et al., published sociedade brasileira de ortopedia e traumatologia - rev bras ortop.2015;50(5):523¿529, reviewed by clinician on 4/20/2018 11:19 am, for reportability determinations.Authors studied 27 shoulders in 24 patients, all utilizing depuy delta xtend implants, for treatment of rotator cuff arthopathy.There were reported 15 complications following the procedure--one report of shoulder dislocation in the immediate post-operative period, and 14 cases of scapular notching.Of the cases of scapular notching, nine were of grade 1 nerot scapular notching and five were grade 2 nerot scapular notching, per radiographic examination follow-ups.It was noted by the authors that patients experiencing scapular notching did not have any significant clinical repercussions or effects from the notching.This complaint will address the one case of shoulder dislocation that occurred in the immediate post-operative period, as the patient was transferred to a bed.It was reported that the patient's humeral component loosened during the dislocation, with treatment requiring surgical intervention, revising the humeral cup polyethylene inlay to a thicker insert.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: null.Device history batch: null.Device history review: null.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 STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7447969
• MDR Text Key: 106092154
• Report Number: 1818910-2018-57961
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention