MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MMX52MM CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994); Local Reaction (2035); Impaired Healing (2378)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04995, 0001825034 - 2019 - 05016.

Event Description

It was reported that following a revision procedure, patient experienced dehiscence with persistent drainage from the surgical site; therefore, superficial incision and drainage of the site was performed.The patient again continued to experience persistent wound complications and underwent a second revision approximately 4 months later.During the revision, the patient was noted to have unresolved adverse reaction to metal debris, trunnion corrosion, and metallosis.The stem was left in place, and all other components were revised without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b1, b6, e4, g3, h2; h3; h6.Reported event was confirmed with medical records provided.Review of the available records identified the following: debridement and revision of right total hip arthroplasty.Pre/postop diagnosis ¿ unresolved armd, persistent wound drainage post partial revision, suspected indolent infection (unconfirmed), suspected systemic cobalt toxicity.Excessive difficulty modifier applied due to complexity of patient condition and complications.Stem at 15° of anteversion, trunnion and head showed some early corrosion, synovial metallosis noted, no acetabular loosening sitting at 60° abduction and 20° anteversion.Sinus tract communicated into the joint space, trochanteric bursa inflamed and debrided, pseudocapsule sent for frozen section showed some acute inflammation.Femoral stem left in place, all other components revised without complication.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 38MMX52MM CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9295058
• MDR Text Key: 165560314
• Report Number: 0001825034-2019-04989
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: N/A
• Device Catalogue Number: RD118852
• Device Lot Number: 394060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ACT ARTIC E1 HIP BRG CAT# EP-200144 LOT# 783940.; BIOLOXD OPTION HD 28MM CAT# 650-1055 LOT# 2898737.; MLRY-HD LAT POR FMRL CAT#11-104210 LOT#174310.; OPTION TYPE 1 SLEVE 6 CAT#650-1068 LOT#2904643.; ACT ARTIC E1 HIP BRG CAT# EP-200144 LOT# 783940; BIOLOXD OPTION HD 28MM CAT# 650-1055 LOT# 2898737; MLRY-HD LAT POR FMRL CAT#11-104210 LOT#174310; OPTION TYPE 1 SLEVE 6 CAT#650-1068 LOT#2904643
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 79