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

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

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.(b)(4).

Event Description

The literature article entitled, "cementless versus cemented glenoid components in conventional total shoulder joint arthroplasty: analysis from the australian orthopaedic association national joint replacement registry" written by richard s.Page, mbbs, bmedsci, fracs, faortha, vishal pai, mbchb, kevin eng, mbbs (hons), fracs, faortha, gregory bain, mbbs, fracs, faortha, phd, stepeh graves, mbbs, fracs, faortha, dphil, and michelle lorimer, bsc (hons) published by journal of shoulder and elbow surgery 2018 was reviewed.The article's purpose was to compare the revision rates of cemented and cementless design glenoid components used in conventional total shoulder arthroplasty (tsa) performed for the diagnosis of osteoarthritis.Data was compiled from the australian orthopaedic association national joint replacement between april 16, 2004 and december 31, 2016 consisting of 10,805 primary conventional tsas.The article notes that depuy products along with non-depuy products are listed under the cemented: all polyethylene glenoid category provided in table 1.The reasons for revisions for the cemented glenoids are listed in table ii but the article does not clarify which specific revision reasons are associated with specifically depuy products.Cement manufacturer is not identified.Depuy product: global/global advantage all poly cemented glenoid, humeral stem, humeral head adverse event(s): revisions for rotator cuff insufficiency, instability and or dislocation, loosening (no further information provided), infection, implant breakage of glenoid, fracture (anatomical location not provided), pain, incorrect sizing (no further information provided to clarify meaning or application of coding), arthrofibrosis, malposition (no further information provided), lysis (no further information provided), glenoid erosion (reference to bone structure and not implant), implant breakage of humeral component.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).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.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.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.

• Brand Name: UNKNOWN SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9941827
• MDR Text Key: 188331865
• Report Number: 1818910-2020-10521
• 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,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHOULDER GLENOID; UNKNOWN SHOULDER HUMERAL HEADS; UNKNOWN SHOULDER HUMERAL STEMS
• Patient Outcome(s): Required Intervention