MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS TROCH CLAW SMALL 100MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 01/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 22-301343 arcos con sz c std 80 mm ha 854650, 22-300918 arcos 18 x 190 mm spl tpr dist ha 176110, 120002 cocr troch cable 2.0 mm x 750 mm 008130, 120010 cocr cable/sleeve set 2.0 mm 900490, 650-0873 32 mm cocr biomet fem hd +3 nk 3123536, 11-302144 arcos lateral troch bolt 44 mm 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 advantage cup, unk double mobility advantage 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.

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.

• Brand Name: ARCOS TROCH CLAW SMALL 100MM
• Type of Device: PROSTHESIS, HIP
• 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: 7837310
• MDR Text Key: 118905513
• Report Number: 0001825034-2018-08606
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 11-302102
• Device Lot Number: 286710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 78