MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 50MM, W/P2 COATING

Catalog Number 430-98-050

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2017

Event Type  malfunction  

Event Description

Primary surgery - the liner would not seat into the cup, was staying 2 mm proud.The surgeon opened a second liner with the same results.The surgeon made sure no tissue or bone was in the way, he also made sure the screws were completely seated.The cup was changed out for another cup of the same size, the surgeon implanted the cup the same way as the first, then the liner snapped in as supposed to without issues.The surgery was completed.

Manufacturer Narrative

Manufacturer narrative: the reason given for this complaint is that two separate acetabular liners would not engage and lock properly with the acetabular shell during the primary surgery.The healthcare professional indicated there was a 10 minute delay in surgery and another suitable device was available for use.The primary surgery was completed as intended.Initial or prolonged hospitalization was required.The device was made available to djo surgical for examination.A review of the device history records (dhrs) revealed no non-conforming material reports (ncmrs) associated with the component listed in the complaint.All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met when the product was released from djo surgical.A review of the product complaint report (pcr) history shows there are (b)(4) prior complaints against the part number 430-98-050 fmp shell, but none are for a similar failure mode to the current complaint.This is the first complaint against lot 588g1147.The fmp shell and the liner were reinspected upon return, for dimensions relevant to assembly and locking of these two components.With the exception of the.040" +/-.002" dimension between the two locking rings of the liner (drawing sheet 2, zone b1), which measured between.035" and.038" on the returned part, both the shell and the liner checked within specification.The out-of-tolerance dimension between the two locking rings is easily explained as deformation due to the initial locking attempt during surgery.Also as part of this investigation, a dome plug was successfully threaded into the bottom of the fmp shell, to verify that it would seat properly and not potentially interfere with the liner during assembly.Finally, the returned liner was turned upside down on a tabletop, the returned shell was placed over the liner, and the two were pressed together with hand pressure.The liner snapped into place and seated fully, as designed.This complaint is therefore not confirmed.The reason given for this complaint is that two separate acetabular liners would not engage and lock properly with the acetabular shell.When the shell was replaced with another, one of the liners immediately engaged and locked with no issues.However, the returned shell and liner are verified to be within specification, and could be fully seated and locked by the investigator with a reasonable assembly force.This complaint is not confirmed.Although debris inside the shell was ruled out by the surgeon, it remains the likely cause and it's possible the debris went unnoticed.Another less likely cause is that the shell may have been tightly pinched in an under-reamed socket, which can deform the shell from its intended circular shape, at least initially.However, there was no information given in the complaint about any additional reaming performed before successfully implanting the second acetabular shell.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FMP HIP
• Type of Device: FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 50MM, W/P2 COATING
• 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: 6450092
• MDR Text Key: 71626858
• Report Number: 1644408-2017-00180
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912099493
• UDI-Public: (01)00888912099493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Catalogue Number: 430-98-050
• Device Lot Number: 588G1147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR