MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 23 MM HEAD HEIGHT 52 MM SPHERICAL HEAD DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has been 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: 0001822565 - 2017 - 07263.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty procedure.Subsequently, the patient is experiencing tightness around the humeral head, looseness around the humeral stem, limited range of motion, numbness, and some degree of pain.It was reported the humeral head was too tight and that the ball of the shoulder was too big.The bone scan was inconclusive.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: trabecular "metalâ-¢" glenoid component 52 mm articular surface cat: 00432605200 lot: 62724270; humeral stem 48 degrees 14 mm stem diameter 130 mm stem length cat: 00434811413 lot: 62528974.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Manufacturer Narrative

The following report is being submitted to report additional information.

Manufacturer Narrative

Udi: (b)(4).

• Brand Name: OFFSET MODULAR HUMERAL HEAD 23 MM HEAD HEIGHT 52 MM SPHERICAL HEAD 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: 6969783
• MDR Text Key: 90003246
• Report Number: 0001822565-2017-07262
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2018

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 Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00430205223
• Device Lot Number: 62621939
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 11/22/2017; 01/16/2018; 02/01/2018
• Supplement Dates FDA Received: 12/18/2017; 01/23/2018; 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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; Other
• Patient Weight: 88