MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER GLENOID; SHOULDER IMPLANTS

Catalog Number UNK SHOULDER GLENOID

Device Problems Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Pain (1994); Paralysis (1997); Loss of Range of Motion (2032); Weakness (2145); Discomfort (2330); Hypoesthesia (2352); Joint Disorder (2373); No Code Available (3191)

Event Date 05/21/2015

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.

Event Description

Patient communication received.As stated, "i had a total replacement shoulder done in 2015.It never seemed like it was working right; after about 6 months or so it felt like it wanted to fall out of socket and weakness in shoulders.Told doctors they keep saying give it time and it will never be the same as previous shoulders; had to have revision in shoulder 2018.Had shoulder replacement on 2015, had trouble with it.Ever since then had a 2nd replacement; should be done on same shoulder on 2018, was told that my shoulder failed due to loose glenoid component with loose glenoid and that caused me much pain over the years after last surgery." doi: 2015 - dor: 2018 (unknown affected side).

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.

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.H10 additional narrative: added: (dob, age & age units) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.Product complaint #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).Update 5-nov-2020: the investigation was re-opened upon receipt of additional information.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 GLENOID
• Type of Device: SHOULDER IMPLANTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8699773
• MDR Text Key: 148019218
• Report Number: 1818910-2019-95982
• 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: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR