MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16X190MM SPL TPR DIST; PROTHESIS, HIP

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 05/19/2023

Event Type  Injury  

Event Description

It was reported the patient was implanted with non-zimmer biomet products.The non-zimmer biomet products were revised for an unknown reason, and the patient was implanted with the arcos stem.The arcos stem was undersized due to an iatrogenic error on the surgeon¿s behalf during the first revision (non-zb to zb products).The patient was revised due to the stem under sizing and dislocation that occurred due to the stem under sizing.There was no need to adjust the acetabular side as it remained stable.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: 11-301353 arcos con sz c hi 80mm (b)(6); 00223200204 integral short gtr w/ 2 cables (b)(6); 00625006550 bone screw self-tapping 6.5 mm dia.50 mm length (b)(6); 00625006550 bone screw self-tapping 6.5 mm dia.50 mm length (b)(6); 00875201336 36mm i.D.Size ll elevated rim liner use with 58mm o.D.Size ll shell (b)(6); 00875705802 58mm o.D.Size ll porous uncemented with multi-holes shell use with ll liners (b)(6); 31-323240 3.2mmx40mm rnglc+ acet drl bit (b)(6); 31-323260 3.2mmx60mm rnglc+ acet drl bit (b)(6); 650-0662 delta ceramic fem hd 36/+3mm (b)(6); 310.250s drill bit 2.5mm, l 110/85mm 2-flute, f/quick coupling 9l85899 depuy.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 01627.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: there is a dislocation of the right hip arthroplasty.Extensive radiolucency along the proximal femoral stem is present as noted.The root cause of the reported issue is attributed to off-label use as it was reported the arcos stem was undersized due to an iatrogenic error on the surgeon's behalf during the first revision.Instructions for use warning section states improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.Complaint confirmed via medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARCOS 16X190MM SPL TPR DIST
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17129254
• MDR Text Key: 317213678
• Report Number: 0001825034-2023-01338
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304474277
• UDI-Public: (01)00880304474277(17)310503(10)943100
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 11-300916
• Device Lot Number: 943100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG