MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN WIRE; FASTENER, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/05/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: depuy 40 mm peg size glenoid component, unknown zimmer tm 48 degree 13 mm x 130 mm humeral component unknown wires.The complaint is under investigation.Once the investigation is done a follow up mdr will be submitted.Product remains implanted.

Event Description

It was reported that patient underwent right initial shoulder arthroplasty procedure and was continuously experiencing pain, from 2 months post implantation.Approximately nineteen (19) months post-implantation, patient underwent a second arthroscopy procedure to remove an unknown wire that was placed in initial surgery due to pain, swelling, burning, numbness, and limited range of motion.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The complaint is confirmed based on the medical records that were provided.Dhr review was unable to be performed as the item and lot number of the device involved in the event is unknown.A depuy glenoid was used in conjunction with a zimmer humeral stem and head which is considered off-label use, however, it is unknown whether this caused or contributed to the event, therefore, with the information provided, a root cause could not 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.

Manufacturer Narrative

Concomitant medical products: cement 61921001 manufactured by howmedica, four sutures manufactured by ethicon, depuy glenoid with crosslink peg, 40 mm pn 113640026, pn 00434811213 ln 60989158 humeral stem 48 degrees 12 mm stem diameter 130 mm stem length, pn 00430204624 ln 60867379 offset modular humeral head 24 mm head height 46 mm spherical head diameter.Investigation is still in progress.A follow up report will be submitted once the investigation is completed.

Event Description

No additional information is available to report at this time.

• Brand Name: UNKNOWN WIRE
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8152606
• MDR Text Key: 129973117
• Report Number: 0001822565-2018-06854
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2019
• 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
• Patient Age: 52 YR
• Patient Weight: 94