MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; STEM, HUMERAL, LONG, REVISION, RSP, SIZE8

Model Number 507-08-175

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 09/17/2018

Event Type  Injury  

Event Description

Revision surgery - due to the stem being loose and causing pain.The surgeon removed the stem, cup and liner as well as the original glenosphere.He removed the cement mantel and replaced with a size 12 primary monoblock cemented stem.Replaced the 36 neutral glenosphere with a 32 neutral for more offset and built the poly to a +12.

Manufacturer Narrative

The reason for this revision surgery was due to the pain.The previous surgery and the revision detailed in this investigation occurred 2.5 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a serious risk to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to the pain.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.Agent has clearly mentioned that "the stem was loose causing pain." it seems that the event may occurred due to inadequate soft tissue support, degenerative bone, patient bone deterioration, excessive range of motion, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

D10 - adding concomitant part 402283.

• Brand Name: RSP SHOULDER
• Type of Device: STEM, HUMERAL, LONG, REVISION, RSP, SIZE8
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 7935055
• MDR Text Key: 122793921
• Report Number: 1644408-2018-00903
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144087
• UDI-Public: (01)00888912144087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 507-08-175
• Device Catalogue Number: 507-08-175
• Device Lot Number: 844C1001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 402283 COBALT G-HV BONE CEMENT 40G; 508-00-000, LOT 848C1973; 508-01-036, LOT 860C1018; 508-36-101, LOT 869C2038
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male