MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 41MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Perforation (2001); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant: xl-115366, acrom xl 44-41 std hmrl brng, 855090.Pm555567, sorensen lt pm mini glen, 082640.The 115396, comp rvs cntrl 6.5 x 30 mm st/rst, 114200.The 115397, comp rvs cntrl 6.5 x 35 mm st/rst, 366060.The 180561, comp nlk scr 3.5hex 4.75x35 st, 203360.The 180560, comp nlk scr 3.5hex 4.75x30 st, 309190.The 115370, comp rvs tray co 44 mm, 935350.The 180559, comp nlk scr 3.5hex 4.75x25 st, 919750.The 118001, versa-dial/comp ti std taper, 323570.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2018-03400.

Event Description

It was reported that a patient underwent a revision surgery.Subsequently, for unknown reasons, the patient has experienced a dislocation as well as penetration of the skin by the implant.No further information is currently available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that a patient underwent a reverse shoulder revision surgery.Photographs were received showing patient dislocated and there was perforation of the skin by the implant.Patient's shoulder was infected, and devices were revised.Currently, the patient has an antibiotic spacer in place awaiting a custom replacement piece for revision.No further information is currently available.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.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.

Manufacturer Narrative

Concomitant medical products: part # xl-115366, acrom xl 44-41 std hmrl brng, lot # 855090 part # cp561425, cust 15cm cps/mos interc, lot # 991960 part # 211218, compr srs prox bdy - lg , lot # 539740 part # 115370, comp rvs tray co 44mm, lot 935350 part # 115320, comp rvrs shldr glnsp std 41mm, lot # 600250 part # cp111044, cps cust short 10mm anchor plg, lot # 763280 part # 178525, cps transverse pin 6pk 24mm, lot # 094450 part # 178526, cps transverse pin 6pk 28mm, lot # 823250 part # cp112306, custom short cps spindle, lot # 377880 part # 178512, cps nut co-cr-mo alloy, lot # 606520 part # cp111171, cps tib spindle 600lb wash set, lot # 384810 part # cp110351, compress 4 bolt concentrc clmp, lot # 365670.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 a patient underwent a reverse shoulder revision surgery.Subsequently, the patient experienced dislocation and perforation of the skin by the implant approximately two (2) years post-implantation.Patient's shoulder was infected, and devices were revised.Currently, the patient has a temporary spacer in place, awaiting a custom replacement piece for revision.No further information is currently available.

• Brand Name: COMP RVRS SHLDR GLNSP STD 41MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7519772
• MDR Text Key: 108452902
• Report Number: 0001825034-2018-03401
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2018

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 Model Number: N/A
• Device Catalogue Number: 115320
• Device Lot Number: 600250
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/24/2018; 11/27/2018; 12/03/2018
• Supplement Dates FDA Received: 05/24/2018; 12/03/2018; 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 62 YR