MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 RTNV+3 HMRL BRG; PROSTHESIS - SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/13/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item#115310; lot#817990 ¿ comp rvrs shldr glnsp std 36mm therapy dates - implanted: jun 2, 2014; explanted: oct 14, 2014.Root cause determined to be patient noncompliance due to alzheimers disease.Conditions are addressed in the package insert.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues reported for these parts.Relayed results to sales rep via email on (b)(6) 2014.Product information updated: review of complaint history found ¿no¿ additional issues reported for item: (b)(4)/lot: 821540 combination.Revision due to dislocation: combination external factors, i.E., patient¿s condition etc., device not returned; known inherent risk of procedure.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.Associated package insert, there are warnings in the package insert, under contraindications, number 1 states, "uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions." under possible adverse effects, number 9 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions." if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient was initially implanted on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2014 due to dislocation.The doctor does not believe it is the fault of biomet products and noted that the patient was noncompliant due to alzheimers disease.The doctor was not able to reduce, so an open reduction was performed.Taper adapter, glenosphere, tray, and poly revised.

• Brand Name: ARCOM XL 44-36 RTNV+3 HMRL BRG
• Type of Device: PROSTHESIS - SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6933766
• MDR Text Key: 89136740
• Report Number: 0001822565-2017-06931
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: XL-115365
• Device Lot Number: 821540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR