MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Pneumonia (2011); Urinary Tract Infection (2120)

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

Article entitled ¿tuberosity union in patients with proximal humerus fractures treated with reverse shoulder arthroplasty: a technical note and exploratory analysis¿ written by florian hess, laurent bohnert, laurenz jaberg, joellen welter, hans-christoph pape, and andrea sireus, published by international orthopaedics on september 22, 2020 was reviewed.The articles purpose was to describe this refixation technique, and present short-term clinical and radiological outcomes from its use in 30 patients.30 patients were implanted with global unite fracture reverse system between june 2018-june 2019.All fractures were fixated with permatape sutures.At final follow up (12 months) no complications such as infection, instability, implant loosening, or a need for revision surgery were detected.Adverse events involving depuy synthes products: 2 patients had a uti (treated with antibiotics).1 patient had post op pneumonia (treated with antibiotics).1 patient developed a post-op hematoma after early post-op substitution of anticoagulants to treat afib.Hematoma was treated conservatively.3 patients were noted to have scapular notching (no treatment indicated) 27/30 patients had adequate tuberosity healing and favorable clinical outcomes.3 additional treatment was noted for the 3 patients without adequate healing.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device associated with this reported event was not returned.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot
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> 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: SHOULDER LOCKING SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12410596
• MDR Text Key: 272293274
• Report Number: 1818910-2021-19132
• Device Sequence Number: 1
• Product Code: PHX
• 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: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention