MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 GLOBAL UNITE STD STEM SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1100-10-100

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616); Naturally Worn (2988)

Patient Problems Pain (1994); Joint Disorder (2373); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 09/01/2020

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

Reason for revision: aseptic loosening leading to dislocation, pain & osteolysis.The reason for revision is dislocation.The cause of the dislocation is uncertain.She is demented, and there is an x-ray documenting a reduced joint three weeks ago.The joint has been painful.Humeral component may be loose.Patient will be revised to a cemented humeral component, though stability may still be an issue.Attended revision case.Primary pe cup and humeral stem were worn and explanted.Surgeon noted 'tarnishing" to the glenosphere, but opted to leave it in-situ due to patient frailty despite advice to exchange it.Cemented delta xtend (long stem) used with new pe cup during revision to restore function.Surgeon believes that oseo-integration of the primary humeral stem never full occured so stem became loose and mal-rotated causing implant impingement & metal on metal contact/wear leading to further aseptic loosening and subsequent osteolysis and dislocation.Action taken :the patient required a revision to a cemented delta xtend long stem with new pe cup.Patient condition: dementia.Female patient initials: m.M height 180cm weight (b)(6).

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.Review of the attached photographs identified the revised products and confirmed the product wear as reported.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot - product code 110010100, work order 8064453 was manufactured on (b)(6) 2015.08 parts were manufactured per specification and all raw materials met specification.No parts were scrapped from lot 8064453.No ncs (non-conformances) found associated with lot 8064453.

• Brand Name: GLOBAL UNITE STD STEM SZ 10
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10541699
• MDR Text Key: 207290329
• Report Number: 1818910-2020-20232
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295004080
• UDI-Public: 10603295004080
• Combination Product (y/n): N
• PMA/PMN Number: K151093
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100-10-100
• Device Catalogue Number: 110010100
• Device Lot Number: 8064453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTHROCARE MULTIFIX P 4.5MM PEEK.; DXTEND GLENOSPHERE STD D38MM.; DXTEND METAGLENE.; DXTEND MOD CENT EPI 1 HA.; DXTEND SCREW LOCK D4.5X30MM.; DXTEND SCREW LOCK D4.5X42MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND STAND PE CUP D38 +9MM.
• Patient Outcome(s): Required Intervention
• Patient Weight: 70