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

Catalog Number UNK SHOULDER HUMERAL HEAD

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

Patient Problems Fall (1848); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994); Discomfort (2330); Joint Laxity (4526); Muscle/Tendon Damage (4532); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled short-term results of a new anatomic stemless shoulder arthroplasty - a prospective multicentre study written by tomas smith, hauke horstmann, roman karkosch, spiros tsamassiotis, nina bowsher, alexander ellwein, and marc-frederic pastor published in orthopedic reviews in 2022 was reviewed.The aim of this prospective multicentre study was to determine the short-term clinical and radiologic outcome of a new stemless design.154 shoulders were involved in the study.All were implanted with the global icon humeral component, global anchor peg glenoid, and humeral head.Adverse events: radiographic images indicated one shoulder had osteolysis.No treatment indicated.Three glenoid fractures post-op -no treatment indicated.Two proximal humerus fracture post op ¿ no treatment indicated.One shoulder with radiographic loosening of the glenoid component with no revision yet performed.One shoulder with intra-op proximal humeral fracture.No treatment indicated.One shoulder sustained a subscapularis tear, and an exchange of the prosthetic humeral head and subscapularis repair was performed 8 months after surgery.10 shoulders sustained pain/discomfort with no treatment indicated.3 shoulders with tendonitis and other tendon disorders with no treatment indicated.3 shoulders with rash and other skin disorders with no treatment indicated.3 shoulders with hematoma with no treatment indicated.2 shoulders with dorsal subluxation with no treatment indicated.2 shoulders with bursitis with no treatment indicated.2 shoulders with rotator cuff syndrome with no treatment indicated.2 patients with neuralgia/paresthesia with no treatment indicated.1 patient with stiffness with no treatment indicated.1 patient with periarthritis with no treatment indicated.1 patient who sustained a fall with breast swelling.No treatment indicated.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN SHOULDER HUMERAL HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15638358
• MDR Text Key: 302065679
• Report Number: 1818910-2022-20946
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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