MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; SHELL, ACETABULAR, FMP SPIKED, NO HOLES SIZE52

Model Number	932-32-250
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/07/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Some complaints forwarded by legal were not entered into our agile system, resulting in late medical device reports.
Event or Problem Description
Reported incident - due to chronic dislocation.The surgeon performed a closed reduction.No implants were removed.
Additional Manufacturer Narrative
Corrected data: removed concomitant and revision surgery date, per quality assurance evaluation.Manufacturer narrative: the reason for this reported incident was due to pain and dislocation.This event did not involve the device being removed.Closed reduction occurred 1.9 years from date of primary surgery.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this reported incident.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was no delay in surgery.The surgery was completed as intended.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 were non-conforming material reports (ncmrs) associated with the device, but they did not contribute to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the primary surgery.Non-conforming material report (nmr) number 7510, which documents a nonconformance that 3 quantity items were rejected for go side not go.This scalloped profile controls the fit between the shell and liner.The failure to pass the go gage indicates that the feature was undersized.Any impact on the mating relationship would have been identified during the implantation process.This issue could not have contributed to the incident reported.Non-conforming material report (nmr) number 7438, which documents a nonconformance that 9 quantity items were rejected for go side of gage does not go into part.This scalloped profile controls the fit between the shell and liner.The failure to pass the go gage indicates that the feature was undersized.Any impact on the mating relationship would have been identified during the implantation process.This issue could not have contributed to the incident reported.8 quantities were rejected for nonconformance, out of tolerance range between.003-.010.This specification is for the outer diameter of the shell.The specification was updated in revision g but these parts were manufactured to revision f.(engineering change order) eco#04471 included the part disposition "use as is" for all parts on order.This issue could not have contributed to the incident reported.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 event is due to pain and dislocation.There were no findings during this analysis that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Reported incident - due to left hip pain.Dislocated left hip.

• Brand Name: FOUNDATION HIP
• Common Device Name: SHELL, ACETABULAR, FMP SPIKED, NO HOLES SIZE52
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7520068
• Report Number: 1644408-2018-00486
• Device Sequence Number: 13812719
• Product Code: LPH
• UDI-Device Identifier: 00888912100038
• UDI-Public: (01)00888912100038
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K973119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 932-32-250
• Device Catalogue Number: 430-05-052
• Device Lot Number: 53870315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2014
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 430-05-052, LOT 53870315
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR