MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP HUMERAL STEM 12MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1130-12-000

Device Problems Loss of or Failure to Bond (1068); Osseointegration Problem (3003)

Patient Problems Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/14/2021

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

Revision of a global ap hemi prosthesis.Primary surgery was performed on (b)(6) 2015.All implants were removed as listed in the impacted products, and a delta xtend was implanted.Surgeon said reason for revision was due to: rotator cuff failure.Glenoid erosion.Humeral stem loosening.

Event Description

Additional information received stated the following: as stated in the event, "humeral stem loosening." can you please confirm what interface was loose? the implant-bone interface was loose.Please confirm if the cement was manufactured by depuy? if yes, please provide the quantity, part and lot numbers of the cement.This is a cementless implant.Please advise of the affected side.Right side.Please advise if this event was due to natural progression? there were multiple potential factors attributing to the revision: there is good evidence showing they hemi procedures are prone to significantly higher revision rates than total replacement.Cuff failure limiting patient rom (may be natural progression).Glenoid wear due to metal-bone articulation.This is a cementless implant without porocoat coating which doesn¿t have the same same level of fixation as our current product global unite.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : 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.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL AP HUMERAL STEM 12MM
• Type of Device: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11737684
• MDR Text Key: 247708014
• Report Number: 1818910-2021-09035
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295005520
• UDI-Public: 10603295005520
• Combination Product (y/n): N
• PMA/PMN Number: K060874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1130-12-000
• Device Catalogue Number: 113012000
• Device Lot Number: 519678
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HEAD 44X15; GLOBAL AP HUMERAL STEM 12MM; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HEAD 44X15; GLOBAL AP HUMERAL STEM 12MM
• Patient Outcome(s): Required Intervention