MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER BIOLOXD OPTION HD 28MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001825034 - 2017 - 11403, 0001825034 - 2017 - 11406, 0001825034 - 2017 - 11407, 0001825034 - 2017 - 11409.Concomitant product(s): unknown product number/lot code, arcos distal stem.Unknown product number/lot code, arcos cone body.Unknown product number/lot code, acetabular cup.Unknown product number/lot code, acetabular liner.Report source: literature.Orthopedics.2016 nov 1;39(6):e1129-e1139.Doi: 10.3928/01477447-20160819-06.Epub 2016 aug 30.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Not returned to manufacturer.

Event Description

It was reported that eleven patients underwent revision due to infection and one patient underwent multiple irrigation and debridement procedures for infection.No further information has been made available at this time.

Manufacturer Narrative

(b)(4).Medical devices: 11-300818, arcos 18x150mm spl tpr dist, 250470; 11-301313, arcos con sz c hi 60mm, 613250; 650-1055, cer bioloxd option hd 28mm, 446590; 650-1066, cer opt type 1 tpr sleve 0mm, 896410; unknown, unknown cup, unknown.

Event Description

It was reported that patient underwent a revision surgery due to infection after 17 days post revision surgery.No additional information is available at this time.

Manufacturer Narrative

The following report is submitted to relay additional information received.11-300818, arcos 18x150mm spl tpr dist, 250470 11-301313, arcos con sz c hi 60mm, 613250 650-1066, cer opt type 1 tpr sleve 0mm, 896410 ep-200154 act artic hip brg 28x48mm 439960 unknown, unknown stryker cup, unknown updated: b7,,,,,, and.The complaint was confirmed based on the surgical operative notes that was provided.Device history records were reviewed and identified no deviations or anomalies.It is reported that a non-zimmer biomet implant was used with the reported biomet components.Zimmer-biomet has not confirmed the compatibility of this combination of devices, and this would be considered an off-label use of this product.However, it cannot be confirmed that this incompatibility has any definitive relationship to the reported event.Hence, the root cause of the reported issue is 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.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7151401
• MDR Text Key: 95938498
• Report Number: 0001825034-2017-11408
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 446590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/18/2018; 05/17/2018
• Supplement Dates FDA Received: 02/16/2018; 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE; SEE NARTIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 141