MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TPR HI CARBON 41/32MM LNR; PROSTHESIS, HIP

Catalog Number 15-105044

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377); Reaction (2414)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown head, pn unknown, ln unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-08904.Customer has indicated that the product will not be returned to zimmer biomet for investigation, (retained by hospital).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient received the first total hip arthroplasty approximately 10 years prior to the revision surgery which was due to pain, severe osteolysis, larger pseudotumor, severely elevated cobalt and chromium levels.Attempts to obtain additional information have been made; however, no more is available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: pn:11-163686, 32mm m2a hi carbon hd -6mm nk ln: 080690; pn x11-180308 bi-metric/x por nc lat 8x120 ln 013230;  pn 10-111154 c2a-t m/h rad 2hl shl 41/54mm ln 555190.Complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: M2A TPR HI CARBON 41/32MM LNR
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7898058
• MDR Text Key: 121024712
• Report Number: 0001825034-2018-08905
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 15-105044
• Device Lot Number: 075190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention