MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY REVISION LENGTH SHOULDER STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Noise, Audible (3273)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

Cmp- (b)(4).Customer has not indicated whether the product will be returned to zimmer biomet for investigation.Product still remains implanted at this time.Once the investigation has been completed, a follow-up mdr will be submitted.Medical products-comprehensive reverse tray catalog#:115370 lot#:488700; comprehensive primary stem catalog#:113668 lot#:044560; central screw catalog#:115396 lot#:402710; locking screw catalog#:180551 lot#:369350; locking screw catalog#:180553 lot#:651160; non-locking screw catalog#: 180558 lot#:030300; non-locking screw.Catalog#:180557 lot#:030260; comprehensive glenosphere catalog#:115310 lot#:383280; humeral bearing catalog#:ep-115393 lot#:864620; steinmann pin catalog#:405800 lot#:572700; drill catalog#:405883 lot#:797890; bone cement catalog#:402433 lot#:003990; hip kit catalog#:417000 lot#:608885; dia drill catalog#:405889 lot#:958000.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02912, 0001825034-2017-02926, 0001825034-2017-02913, 0001825034-2017-02931, 0001825034-2017-02884, 0001825034-2017-03047, 0001825034-2017-03048, 0001825034-2017-03049, 0001825034-2017-03050, 0001825034-2017-03053, 0001825034-2017-03052, 0001825034-2017-03051, 0001825034-2017-01739.

Event Description

It is reported the patient underwent a reverse shoulder arthroplasty.Subsequently, approximately two (2) years post-operatively, the patient experienced a loud pop in the shoulder and pain.Subsequent radiographs revealed a peri-prosthetic fracture and indications that the humeral tray may be loosening or disconnecting from the humeral stem.No revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 is reported the patient underwent a reverse shoulder arthroplasty.Subsequently, approximately two (2) years post-operatively, the patient experienced a loud pop in the shoulder and pain.Subsequent radiographs revealed a peri-prosthetic fracture and indications that the humeral tray may be loosening or disconnecting from the humeral stem.Patient was later revised to a custom reverse shoulder transplant.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required x-ray review impressions: earlier x-rays show right shoulder hemi-resurfacing arthroplasty with loosening of the humeral component and superior subluxation of the humerus indicative of superior rotator cuff deficiency.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM PRIMARY REVISION LENGTH SHOULDER STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6569188
• MDR Text Key: 75248008
• Report Number: 0001825034-2017-03302
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 113668
• Device Lot Number: 044560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 09/15/2017; 12/12/2017
• Supplement Dates FDA Received: 10/11/2017; 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2009
• 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
• Treatment: REFERENCE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 57