MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Tissue Breakdown (2681)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Multiple mdr reports were submitted for this event.Please see reports: 0001825034 - 2017 - 07343; 0001825034 - 2017 - 07349; 0001825034 - 2017 - 07350.(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported patient underwent left shoulder revision due to dislocation secondary to loss of soft tissue function.

Manufacturer Narrative

This follow up report is being submitted to relay corrected information.The following sections were corrected: brand name, type of device, additional device information, 510k number, device manufacturer date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: comprehensive reverse shoulder glnsp +3 36mm, item # 115313, lot # 434000; comprehensive reverse primary stem 6 x 194, item # 113666, lot 503390; comprehensive reverse shoulder 9 in steinmann, item # 405800, lot 930600; comprehensive reverse tray +10mm co 44mm, item # 115378, lot 621420; comprehensive reverse lk screw 3.5hex 4.75x20 st, item 180551, lot # 196430; comprehensive reverse lk screw 3.5hex 4.75x20 st, item 180551, lot # 488590; versa-dial taper adaptor 25mm, item # 110031378, lot 716090; comprehensive reverse glen pps min tpr adr, item # 110027734, lot # 716060; comprehensive reverse scr 3.5hex 4.75x30 st # item 180553, lot # 333540; comprehensive reverse lk scr 3.5hex 4.75x35 st, item # 180554, lot 095420; comprehensive reverse cntrl 6.5x35mm st/rst, item # 115397, lot # 927940; comprehensive reverse bone and imp mdl, item # 110031178, lot # 716100.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2017-07343-1.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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.

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.

• Brand Name: ARCOM XL HUMERAL BEARING
• 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: 6894254
• MDR Text Key: 87371486
• Report Number: 0001825034-2017-07349
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2018

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: 03/07/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115365
• Device Lot Number: 358590
• Other Device ID Number: (01) 0 0880304 47551 9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 08/30/2017; 01/30/2018; 02/02/2018
• Supplement Dates FDA Received: 09/28/2017; 02/01/2018; 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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: (B)(4) COMP RVSR SHLDR LOT 434000; (B)(4) VERSA-DIAL TAPER ADAPTOR LOT 716090
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR