MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD HMRL BRNG; PROSTHESIS, SHOULDER

Model Number XL-115363

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 115738 427050 compr nano hmrl pps 38mm; 115370 561960 comp rvs tray co 44mm; 115310 827220 comp rvrs shldr glnsp std 36mm; 115330 881390 comp rvrs shdr glen bsplt +ha; 118001 223240 versa-dial/comp ti std taper; 115396 448270 comp rvs cntrl 6.5x30mm st/rst; 180551 046030 comp lk scr 3.5hex 4.75x20 st; 180551 046030 comp lk scr 3.5hex 4.75x20 st; 180551 670210 comp lk scr 3.5hex 4.75x20 s; 180552 095350 comp lk scr 3.5hex 4.75x25 st.Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00384, 0001825034 - 2021 - 00385, 0001825034 - 2021 - 00387, 0001825034 - 2021 - 00388, 0001825034 - 2021 - 00389, 0001825034 - 2021 - 00390, 0001825034 - 2021 - 00391, 0001825034 - 2021 - 00392, 0001825034 - 2021 - 00393, 0001825034 - 2021 - 00394.

Event Description

It was reported that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, the patient has had on going issues of pain, noise (crepitus), and difficulty performing activities of daily living since the one-year visit.It is further reported the patient is scheduled for open biopsy to investigate the possible cause, such as possible underlying infection, currently remains implanted.No revision procedure has been reported to date.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs/ medical records.Review of the available records identified the following: six week visit on (b)(6) 2017.Radiographic evaluation: no radiolucency, implant fracture, or migration.Zero notching.Six month visit on (b)(6) 2017.Radiographic evaluation: no radiolucency, implant fracture, or migration.Zero notching.One year visit on (b)(6) 2018.Radiographic evaluation: no radiolucency, implant fracture, or migration.Zero notching.Pain associated with poor activation.Two year visit on (b)(6) 2019.Radiographic evaluation: no radiolucency, implant fracture, or migration.Zero notching.Sclerotic line seen in proximal humerus.Three year visit on (b)(6) 2021.Radiographic evaluation: no radiolucency, implant fracture, or migration.Zero notching.Sclerotic line seen in proximal humerus.Unusual shoulder pain.Possibly procedure related.States device related.Listed for open biopsy right shoulder to investigate for infection.Blood taken for fbc, esr and crp- all negative.No revision has occurred.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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

No further event information available at the time of this report.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The report of noise/crepitus/catching are related to patient anatomy and not device.In addition, the device can be ruled out as causing/contributing to infection with conforming sterile certs.The initial report should be voided.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 44-36 STD HMRL BRNG
• 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: 11292713
• MDR Text Key: 230717908
• Report Number: 0001825034-2021-00386
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)220218(10)370710
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: XL-115363
• Device Catalogue Number: XL-115363
• Device Lot Number: 370710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 95 KG