MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 38MM MOD HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see reports: 0001825034 - 2017 - 06834, 0001825034 - 2017 - 06835.Concomitant product(s):- p/n 11-173662 m2a 38mm mod hd std nk l/n 057180.P/n 15-106052 m2a-38 52mm cup non flared l/n 068130.P/n 11-103200 taperloc por lat fmrl 5.0x130 l/n 772480.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient was revised due to pain, discomfort, soreness, dysfunction, loss of range of motion, and noise.Metallosis was noted intraoperatively.No further information is available at this time.

Manufacturer Narrative

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 relevant to the reported event were found.Review of the complaint history determined that no further actions are required.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.

Manufacturer Narrative

This follow-up report is submitted to relay additional information: multiple mdr reports were filed for this event.Please see reports: 0001825034 - 2017 - 06834; 0001825034 - 2017 - 06835; 0001825034 - 2018 - 00071.

Event Description

It was reported the patient was revised due to pain, osteolysis discomfort, soreness, dysfunction, loss of range of motion, and noise.Metallosis was noted intraoperatively.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed through review of medical records.The revision operative notes state that the trunnion showed minimal corrosion after the femoral head was removed.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

It was reported that the patient had a right hip revision approximately 8 years post primary surgery, due to pain, discomfort, soreness, dysfunction, loss of range of motion, and noise.During the revision, metallosis, osteolysis and pseudo-tumor were found.Head and cup were removed.New head and competitor's cup and liner were implanted.No further information is available at this time.

• Brand Name: M2A 38MM MOD HD STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6845493
• MDR Text Key: 85002739
• Report Number: 0001825034-2017-06834
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 11-173662
• Device Lot Number: 057180
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 10/19/2017; 12/21/2017; 01/22/2018
• Supplement Dates FDA Received: 10/19/2017; 01/15/2018; 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• 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: 83 YR