MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP SRS DISC 50MM DST BDY LT; PROSTHESIS, EXTREMITIES

Catalog Number 211250

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Decreased Sensitivity (2683); Patient Problem/Medical Problem (2688)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 patient underwent an elbow arthroplasty revision approximately three (3) years ago.Subsequently, patient underwent a second revision approximately six (6) weeks ago due to perioprosthetic fracture, pain, migration, radiolucency, altered sensation, and limited ability to do activities of daily living.Onset of pain occurred during physical therapy at an unknown date.It was noted that the patient alleged the therapist of being too aggressive during therapy.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The event is still under investigation.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

Additional information was received and it was reported the patient also experienced loosening of the ulnar component.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: six month followup ¿ (b)(6) 2018 no pain.Moderately limited in work or other regular daily activities.Radiolucency >2mm at the proximal around ulnar component.Evidence of component migration.Periprosthetic fracture of the ulnar component.Pt.Attended physical therapy.Satisfaction scale 010.Pt.States 7.Adverse event onset (b)(6) 2018 revision surgery planned due to fracture progression.Distal srs.Pending patient states the physiotherapy was too aggressive and caused the fracture.Pt.Performing the physiotherapy exercises felt sudden onset of pain.Adverse event onset (b)(6) 2018 revised distal srs with custom made ulna (b)(6) 2020.One year followup ¿ (b)(6) 2018 severe pain.Very limited in adl¿s.Tingling (pins & needles) in the arm or hand.Radiolucency 15 mm at the proximal around ulnar component.Evidence of component migration (ulnar).Satisfaction scale 010.Pt.States 0.Lost to follow up ¿ 11 september 2020 ltfu due to revision surgery.Op record (b)(6) 2020: loose ulna w/fracture, samples taken, no results provided, ulna reamed, and perforated distally ¿ notes narrow nature of ulna, implanted with custom ulna component, srs distal humerus, noted good soft tissue coverage, no complications.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive 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.

Event Description

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

• Brand Name: COMP SRS DISC 50MM DST BDY LT
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10726216
• MDR Text Key: 212715821
• Report Number: 0001825034-2020-03875
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 74