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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Pain (1994); Hip Fracture (2349); Ambulation Difficulties (2544)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: cat#22-300916; lot#379520 - arcos 16x190mm spl tpr dist ha; cat#650-0840; lot#2754109 - 36mm cocr biomet fem hd -3 nk; cat#pt-106056; lot#389700 - regen/rnglc+ multi 56mm sz 24; cat#ep-105894; lot#427480 - ringloc 36mm epoly lnr 10 deg sz24; cat#350806; lot#283490 - 2.0 mm ss cable/sleeve combo; cat#350806; lot#203530 - 2.0 mm ss cable/sleeve combo; cat#350806; lot#111410 - 2.0 mm ss cable/sleeve combo.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.Related mfr reports: 0001825034-2017-10931; 0001825034-2017-10932; 0001825034-2017-10934; 0001825034-2017-10935; 0001825034-2018-08664; 0001825034-2018-08665; 0001825034-2018-08666.

Event Description

It was reported that the patient underwent initial right hip surgery on an unknown date and was revised due to loosening (b)(6) 2014.Subsequently patient experienced problems walking about, problems washing or dressing, moderate pain (may take aspirin), a moderate limp, moderate trouble getting in or out of the car, moderate difficulty putting on socks, noted it was impossible to shop, extremely difficult to climb stairs, moderately painful to stand up, and unable to perform usual activities at 3 year follow up visit on (b)(6) 2016.The patient was also using 2 crutches or a walker at the 3 year visit.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The additional information provided does not change the previously submitted investigation.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: ARCOS 16X190MM SPL TPR DIST HA
• Type of Device: PROSTHESIS - HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7837297
• MDR Text Key: 118904403
• Report Number: 0001825034-2017-10931
• Device Sequence Number: 1
• Product Code: KWY
• 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
• Report Date: 10/11/2018

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 22-300916
• Device Lot Number: 379520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 60