MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL

Model Number 508-36-101

Device Problems Mechanical Problem (1384); Material Separation (1562); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 05/28/2019

Event Type  Injury  

Event Description

Revision surgery - due to the glenosphere coming apart from the baseplate.Surgeon wasn't sure if morse taper wasn't properly engaged in primary surgery or if a couple baseplate screws were sitting proud and prevented morse taper from engaging.

Manufacturer Narrative

The reason for this revision surgery was due to disassociation.The previous surgery and the surgery detailed in this investigation occurred 4.3 months apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.Initial or prolonged hospitalization was required.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, when released for use, met design and manufacturing requirements.There was a non-conforming material report, ncmr number (b)(4), assosicated with (b)(4) lot# 869c2478: lot quantity-15, sample quantity-5, reject quantity-15, failure code-d10 - inspection error, cause code-th01 - operator error outside of first piece setup, revision found-e, defect description-at op20 is20435, 5 deg.44 mininute 30 seconds has a recorded sample of 5 parts, specification requirements-100% inspection of dimension 5 degree 44 minuntes 30 seconds, disposition-rework, justification-split lot to new re sterilization work order maintaining lot number.Add step to router to re-inspect per is201.3 features/dimensions: (5°44'30" + 0°0'0"/-0°5'30", air gage, s1c1, 100%), (circularity.0013, cmm, s1b2, 100%), and (perpendicularity.0007 to datum a, cmm, s1b1, 100%).Lot quantity-15, sample quantity-5, reject quantity-15, failure code-d10 - inspection error, cause code-th01 - operator error outside of first piece setup, revision found-e, defect description-at op60 is20438, cmm data has out of tolerance dimensions, specification requirements-re-run or scrap out of tolerance parts, disposition-rework, justification-split lot to new re sterilization work order maintaining lot number.Add step to router to re-inspect per is201.3 features/dimensions: (5°44'30" + 0°0'0"/-0°5'30", air gage, s1c1, 100%), (circularity.0013, cmm, s1b2, 100%), and (perpendicularity.0007 to datum a, cmm, s1b1, 100%).The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of 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 disassociation.There were no findings during this investigation that indicate that the reported device was defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Infection complaint.

• Brand Name: RSP
• Type of Device: GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8742842
• MDR Text Key: 149471534
• Report Number: 1644408-2019-00599
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024761
• UDI-Public: (01)00888912024761
• Combination Product (y/n): N
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

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
• Device Operator: Health Professional
• Device Model Number: 508-36-101
• Device Catalogue Number: 508-36-101
• Device Lot Number: 869C2478
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-126, LOT 834C1527; 506-03-130, LOT 835C1492; 508-01-036, LOT 860C1928; 506-03-126, LOT 834C1527; 506-03-130, LOT 835C1492; 508-01-036, LOT 860C1928
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR