MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Pain (1994)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00434901013, tm reverse humeral stem, 63399934.

Event Description

It was reported that a patient underwent an initial shoulder procedure.Subsequently, the patient was revised due to loosening, breakage, and pain.It was also reported that the poly liner became disengaged with the stem, and the liner had to be replaced.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).The reported event is confirmed via op notes.Products were returned; therefore, the visual inspection of the returned products exhibited nicks and gouges.Liner was cut at two places,and showed marks which are consistent with impacting the liner without aligning the liner slot with the post on stem.However, as the liner disassociated from the stem, it is unknown if the damage was caused during impaction or after.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Review of the op notes identified that the polyethylene was disengaged from the humerus.They also noted that the radiographs showed dislocation of the left reverse shoulder arthroplasty.The surgical technique states that the guide pin on the poly liner impactor should align into the post on the lateral side of the stem face prior to impaction.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 shoulder arthroplasty revision approximately seven (7) months post-implantation due to polyethylene liner disassociation resulting in pain, loss of range of motion, and instability.No further information provided.

• Brand Name: POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6905689
• MDR Text Key: 87845077
• Report Number: 0001822565-2017-06734
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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: 00434904003
• Device Lot Number: 63381083
• Other Device ID Number: (01) 00889024269149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR