MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2, 39MM DIA, +6, 10 DEG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWR1396
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient was happy with his progress and performing activities of daily living without complaint post rsa in (b)(6) of 2020.The patient had a 39 standard glenosphere on a 29 +3 baseplate with a long post.On the humeral side he had a 2+ stem and a 10 degree ½ 39 +6 poly.The patient had a fall.He had pain and limited function after the fall.The patient was seen in the er and appeared to have a poly dissociation.Revision surgery was scheduled for later that day ((b)(6) 2022).Revision surgery ((b)(6) 2022): the poly was completely out of the stem.The ring was retained within the stem.Both the poly and locking ring were removed.A spacer with +0 poly was trialed with good stability and motion.This was implanted in the patient.
Additional Manufacturer Narrative
Correction g1 manufacturing site.The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: visual inspection a visual inspection revealed the returned poly insert (dwr1396) to be significantly deformed at the base of the device.The metal ring that circumvents the device is missing.There are several scratches on various surfaces of the poly as well.Functional inspection: a functional inspection could not be performed due to the physical condition of the returned device.Based on analysis of the returned component and provided information, the root cause was attributed to a patient related issue.The complaint details state, ¿the patient was sledding with his grandson¿s last week, stepped on a sled, and fell on his outstretched arm.He had pain and limited function after the fall.The patient was seen in the er and appeared to have a poly dissociation.¿ the ifu notates that falling can threaten the success of the implant and that surgeons should ¿inform patients about precautions to take in daily life to guarantee maximum implant survival.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient was happy with his progress and performing activities of daily living without complaint post rsa in (b)(6) of 2020.The patient had a 39 standard glenosphere on a 29 +3 baseplate with a long post.On the humeral side he had a 2+ stem and a 10 degree ½ 39 +6 poly.The patient had a fall.He had pain and limited function after the fall.The patient was seen in the er and appeared to have a poly dissociation.Revision surgery was scheduled for later that day ((b)(6) 2022).Revision surgery ((b)(6) 2022): the poly was completely out of the stem.The ring was retained within the stem.Both the poly and locking ring were removed.A spacer with +0 poly was trialed with good stability and motion.This was implanted in the patient.

• Brand Name: PERFORM REV INSERT SZ 1/2, 39MM DIA, +6, 10 DEG
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork MN NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13734685
• Report Number: 3004983210-2022-00047
• Device Sequence Number: 14695146
• Product Code: PHX
• UDI-Device Identifier: 00846832084807
• UDI-Public: 00846832084807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/14/2025
• Device Model Number: DWR1396
• Device Catalogue Number: DWR1396
• Device Lot Number: AD2414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown