MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; EXTREMITIES, IMPLANT

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Fracture (1260); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 115370, lot# 108730, comp rvs tray co 44mm.It is unknown if product will be returning to zimmer biomet and 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 - 02629.Product not returned.

Event Description

It was reported that the patient underwent a revision due to pain, screw fracture around baseplate, loosening and spine stress fracture.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi# (b)(4).Concomitant medical products : item# 115397; comp rvs cntrl 6.5x35mm st/rst; lot# 335170, item# 180554; comp lk scr 3.5hex 4.75x35 st; lot# 657980, item# 180554; comp lk scr 3.5hex 4.75x35 st; lot# 479080, item# 115370; comp rvs tray co 44mm; lot# 108730.Reported event was confirmed by review of medical records which states that primary surgery was done due to degenerative joint disease of the right shoulder with rotator cuff tear (massive retracted tear that appeared to be unrepairable.A very large area of grade 3 & 4 chondromalacia about 4-5 cm over the superior dome of the humeral head and inferior aspect of the glenoid.A subdeltoid, subacromial, subconjoint tendon releases were performed.The biceps tendon was tenotimized.The humerus was osteotomized at 20 degrees of retroversion at the 45-degree inclination angle.The anterior-inferior capsule of the glenoid was completely removed.A 41 +3 head was impacted in the c-position.The shoulder was very stable through all ranges of motion.No complications noted.Revision surgery was done due to pain, loosening, implant fracture, metallosis, instability, and wear.X-rays revealed broken screws around the baseplate, the baseplate was loose, and scapular spine stress fracture.Multiple aspirations ruled out infection.Pseudocapsule was identified and removed.Cultures and gram stain sent (no report provided).No purulence.There was some metallosis from the patients instability.All three screws were broken.Significant anterior-superior wear to the glenoid.All products were removed easily.Device history record was reviewed and no discrepancies 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.Multiple mdr reports were filed for this event: 0001825034-2019-04078, 0001825034-2019-04080, 0001825034-2019-04082, 0001825034-2019-02629.

Event Description

It was reported patient underwent a revision procedure approximately one post-implantation due to pain, loosening, implant fracture, metallosis, instability, and wear.No additional patient consequences were reported.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8732751
• MDR Text Key: 149133059
• Report Number: 0001825034-2019-02628
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000589
• Device Lot Number: 336680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention