MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ C STD 80MM HA; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 01/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2018 - 01517, 0001825034 - 2018 - 01518.(b)(6).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no furth er action is required as no were trends 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.Device remains implanted.

Event Description

It was reported in (b)(6) the patient had wound dehiscence post op.No further information has been made available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.

Event Description

It was reported that the patient underwent a right hip revision surgery.Subsequently, the patient experienced wound dehiscence.Patient was treated with debridement, cultures, and prophylactic antibiotics.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Concomitant medical products: 22-301343 arcos con sz c std 80mm ha 854650, 22-300918 arcos 18x190mm spl tpr dist ha 176110, 120002 cocr troch cable 2.0mmx750mm 008130, 120010 cocr cable/sleeve set 2.0mm 900490, 650-0873 32mm cocr biomet fem hd +3 nk 3123536, 11-302144 arcos lateral troch bolt 44mm 566380, 00625006515 bone scr 6.5x15 self-tap 62566993, 00625006520 bone scr 6.5x20 self-tap 62256199, 00625006520 bone scr 6.5x20 self-tap 62748069, 00625006540 bone scr 6.5x40 self-tap 62440464, unk double mobility avantage cup, unk double mobility avantage insert.Report source: foreign.The event occurred in (b)(6).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends 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.Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2018 - 01516, 0001825034 - 2018 - 01517, 0001825034 - 2018 - 08605, 0001825034 - 2018 - 08607.

• Brand Name: ARCOS CON SZ C STD 80MM HA
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7320858
• MDR Text Key: 101767608
• Report Number: 0001825034-2018-01516
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2018

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 22-301343
• Device Lot Number: 854650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 05/09/2018; 07/17/2018
• Supplement Dates FDA Received: 05/15/2018; 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 22-300918 ARCOS 18X190MM SPL LOT 176110; 650-0873 32MM COCR FEM HD +3 NK LOT 3123536; 22-300918 ARCOS 18X190MM SPL LOT 176110; 650-0873 32MM COCR FEM HD +3 NK LOT 3123536
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 78