MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER HUMERAL HEAD GLOBAL

Catalog Number UNK SHOULDER HUMERAL HEAD GLOB

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)

Event Date 11/16/2017

Event Type  Injury  

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.

Event Description

Literature article entitled, "seven-year survival analysis of the global cap (conservative anatomic prosthesis) shoulder resurfacing", by helen ingoe, et al, published by shoulder & elbow, 2018, volume 10(2) 87-29, was reviewed.The study presents a survival and functional outcome analysis of the global cap hemi-resurfacing implanted by multiple surgeons with up to 10 years of follow-up.Two survival analyses were performed; first, where failure was defined as component revision and, second, where failure was defined as re-operation for any reason.Postoperative functional outcome was quantified using quick dash and oxford shoulder scoring measures.Eighty-seven depuy global caps were implanted in 75 patients, ten of which were cuff tear arthroplasty (cta) prosthesis variants to address patients presenting with rotator cuff deficiencies (none of the cta prosthesis required revision).Four patients underwent a reoperation without component exchange, while five patients underwent component revision.The reason for revision in our five patients was multi-factorial.Two patients had rotator cuff failure, resulting in conversion to a reverse total shoulder arthroplasty.The other three revisions had ongoing pain, caused by the unresurfaced glenoid.On axial radiographs, two patients had central glenoid erosion to the level of the coracoid, and one had anterior glenoid erosion to the same level.One of these was found to be aseptically loose at the time of revision and one required bone grafting of a contained defect at revision.There was no bone loss for any patient that was sufficiently great to preclude revision surgery.The primary indication for reoperation without revision was an arthroscopic subacromial decompression for impingement.Three patients experienced heterotopic ossification.Finally, there were nine patients who expired over the lid of the study¿no death was attributable to the surgery.The global cap prosthesis has a similar survival to registry data.It has a higher early revision rate compared to conventional shoulder arthroplasties, which may be a result of both the ease of revision and other implant-related factors.An unexplained distribution of functional outcomes was observed: either having very good or very poor function, suggesting the need for further study.The study did not provide specific information per study subject (id, age, gender), nor any specific product information.It was not possible to determine possible overlay of adverse events affecting the same individuals, so each is broken out separately for purposes of this complaint.2 were revised to address rotator cuff deficiency (tendon injury).2 were revised to address pain and native glenoid erosion.1 was revised to address pain and native glenoid erosion, and implant loosening of the cap.4 received arthroscopic subacromial decompressions for impingement.3 patients developed heterotopic ossification.Of the remaining 75 patients, the study presented results of functional outcomes indicating pain and disability of varying degrees, per survey results.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK SHOULDER HUMERAL HEAD GLOBAL
• Type of Device: SHOULDER HUMERAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11229108
• MDR Text Key: 229094269
• Report Number: 1818910-2021-01810
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD GLOB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention