MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD +3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-103203 taperloc por lat fmrl 9x137 667660.Rd118854 m2a 38mmx54mm cup 283081.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05773 taper.0001825034 - 2019 - 05774 cup.

Event Description

It was reported by 411 group that patient underwent left total hip arthroplasty sixteen years prior.Subsequently, patient may undergo a revision on an unknown date due to squeaking, discomfort and cysts in pelvis.Sales rep was inquiring about implant records.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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.

Event Description

No further event information available at the time of this report.

• Brand Name: M2A 38MM MOD HD +3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9524222
• MDR Text Key: 188994559
• Report Number: 0001825034-2019-05775
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-173663
• Device Lot Number: 421620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other