MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; LINER, METAL-METAL 28XMP5

Catalog Number 499-28-005

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 01/25/2017

Event Type  Injury  

Event Description

Revision surgery - due to suspected metal liner (inlay) wear against poly cup.The remaining originally-implanted djo head, cup and liner were replaced with products from another brand.During the revision procedure, the inlay easily came off from the liner.

Manufacturer Narrative

Corrected data: concomitant medical product: corrected a lot number that was reported on the initial medical device report.Manufacturer narrative: the reason for this revision surgery was a loosening of the acetabular shell due to bone absorption.Wear of the patient's metal-on-metal liner was also suspected.The implants were in the patient for approximately 6 years, 8.5 months prior to revision.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.The device was made available to djo surgical for examination.A review of the device history records showed no non-conforming material reports associated with the main contributor component listed in the complaint.The dhr evidence that all critical dimensions and specifications were met when the product was released from djo surgical.A review of the product complaint report history for part number 499-28-005 metal-metal liner, there are 13 prior complaints.Only one of these, (b)(4) from may 2011, described the metal inlay separating from the poly component.An additional six complaints described elevated metal levels in the blood, which can result from wear of the metal-metal liner.It is not known from the complaint description whether this was a factor in the current complaint.The current complaint is the first for lot number 53768840.The returned product was visually inspected and photographed.The poly component and the cocr inlay component of the part number 499-28-005 metal-metal liner are separated, consistent with statements in the complaint.The spherical inside diameter of the inlay component is in excellent condition.The spherical outside diameter of the inlay shows some evidence of rotation within the poly component.Circular swirl marks are visible on the grit blasted surface, indicating that the inlay has been turning against the poly liner in vivo.The poly liner component is badly damaged from the removal process.Circular swirl marks are visible on the spherical inside diameter of the poly component, again due to the inlay turning against the poly liner in vivo.A hairline crack is visible completely through the wall of the poly component in between two of the scallop features.Normally the press fit of the cocr inlay in the poly component of the liner restrains the inlay from rotating.However, the presence of the crack may have relaxed the press fit to some extent and allowed inlay rotation to begin.Continued rotation would then cause wear between the two components, and a further loosening of the press fit.Two key dimensions were measured on the cocr inlay component.The overall height of the inlay was measured as 0.695" versus a specification of 0.697" +/- 0.002", within tolerance.The wall thickness at the apex of the inlay was measured as 0.126" versus a specification of 0.124" +/- 0.002", also within tolerance.Based on these measurements, the cocr inlay is not significantly worn, if at all.The same dimensions were measured on the poly liner component.The overall height of the poly component was measured as 0.929" versus a specification of 0.936" +/- 0.010", within tolerance.The wall thickness at the apex of the poly component was measured as 0.074" versus a specification of 0.1095" to 0.1165".The poly wall thickness is significantly under tolerance compared to a new part.This is likely due to a combination of: normal compression of the poly material under the patient's body weight, and wear of the poly material due to rotation of the grit-blasted surface of the cocr inlay against the poly component.The reason for revision as stated in the complaint was a loosening acetabular shell due to bone absorption.The surgeon also found the cocr inlay to be loose within the poly component of the liner.There is evidence that the cocr inlay had rotated against the poly component in vivo, with further evidence of wear of the poly component.The wear is likely due to the rotating inlay.A hairline crack was found in the poly component; this may have been the root cause which allowed the cocr inlay to begin rotating.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The dhr evidences that all critical dimensions and specifications were met when the products were released from djo surgical, and the revision surgery was completed as intended.

• Brand Name: FMP HIP
• Type of Device: LINER, METAL-METAL 28XMP5
• 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 ; 5128346255
• MDR Report Key: 6360786
• MDR Text Key: 68404949
• Report Number: 1644408-2017-00164
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00888912087643
• UDI-Public: (01)00888912087643
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003250
• 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: 06/06/2017

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 Expiration Date: 02/28/2011
• Device Catalogue Number: 499-28-005
• Device Lot Number: 53768840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2006
• 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: 010-55-020,LOT 54014673; 497-28-035,LOT 53768840
• Patient Outcome(s): Required Intervention