MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT M/S PSL SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 2017-0054

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Peeled/Delaminated (1454); Mechanical Jam (2983); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Revised the omnifit cup due to loosening.X-ray taken prior to revision showed beads peeling from the cap.During the revision procedure surgeon changed the cup and plate.Completed the procedure.

Manufacturer Narrative

Corrected data: catalog #.An event regarding alleged "loosening of the shell" involving a omnifit m/s psl shell 54mm was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis was performed and concluded that "no indications of bone in-growth was observed on the beaded side of the acetabular shell, however the regions where beads were missing could not be evaluated.Impingement was observed on the insert as well as a region of sub-surface delamination and cracking.It is likely that this region occurred due to the loading conditions created from the impingement and contact between the rim of the insert and the femoral head.Dislodged beads from the omnifit shell became imbedded in the insert.The adhered material, scratching and markings seen on the metal head came from the beads dislodged from the omnifit shell.The exact cause of the beads coming off the shell could not be determined.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: a review of the undated x-rays and material analysis report by the consulting clinician indicated "no clinical or past medical history, no patient demographics, no primary or revision operative reports, and no dates of surgery are available.The event was apparently revision for acetabular loosening and bead dehiscence noted from an acetabular shell with beads imbedded in the insert.X-ray printouts include three undated ap x-rays of the left hip demonstrating a left total hip arthroplasty with broken trochanteric reattachment wires, a loose vertical psl acetabular component with multiple fine radiodensities in the acetabular zone iii consistent with metallic beads.A material analysis report dated (b)(6) 2017 of a 52 omnifit m/s psl shell, a poly liner and a metal head include eight photographs of the explanted components, two sem images of the zone of the acetabular shell with beads next to a region with lost beads, one sem of the insert with imbedded titanium beads, one eds graph of the adherent metal on the head, one eds graph of the base material of the bead material in the shell, and one eds graph of the bead material on the insert.The conclusions of this report are: no bone ingrowth was observed in beaded site of the acetabular shell; impingement observed on the insert and region of the subsurface delamination and cracking likely due to contact between the rim of the insert and the femoral head; dislodged beads from the omnifit shell were imbedded in the insert; the adherent material on the head came from the beads; the cause of the beads coming off the shell could not be determined; and no material or manufacturing defects were observed.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation." -device history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: a review of the undated x-rays and material analysis report by the consulting clinician indicated "no clinical or past medical history, no patient demographics, no primary or revision operative reports, and no dates of surgery are available.The event was apparently revision for acetabular loosening and bead dehiscence noted from an acetabular shell with beads imbedded in the insert.X-ray printouts include three undated ap x-rays of the left hip demonstrating a left total hip arthroplasty with broken trochanteric reattachment wires, a loose vertical psl acetabular component with multiple fine radiodensities in the acetabular zone iii consistent with metallic beads.A material analysis report dated (b)(6) 2017 of a 52 omnifit m/s psl shell, a poly liner and a metal head include eight photographs of the explanted components, two sem images of the zone of the acetabular shell with beads next to a region with lost beads, one sem of the insert with imbedded titanium beads, one eds graph of the adherent metal on the head, one eds graph of the base material of the bead material in the shell, and one eds graph of the bead material on the insert.The conclusions of this report are: no bone ingrowth was observed in beaded site of the acetabular shell; impingement observed on the insert and region of the subsurface delamination and cracking likely due to contact between the rim of the insert and the femoral head; dislodged beads from the omnifit shell were imbedded in the insert; the adherent material on the head came from the beads; the cause of the beads coming off the shell could not be determined; and no material or manufacturing defects were observed.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation." no further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

Revised the omnifit cup due to loosening.X-ray taken prior to revision showed beads peeling from the cap.During the revision procedure surgeon changed the cup and plate.Completed the procedure.Event update based on review of the medical records by consulting clinician dated (b)(6) 2017: x-ray printouts include three undated ap x-rays of the left hip demonstrating a left total hip arthroplasty with broken trochanteric reattachment wires, a loose vertical psl acetabular component with multiple fine radiodensities in the acetabular zone iii consistent with metallic beads.

• Brand Name: OMNIFIT M/S PSL SHELL 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6385570
• MDR Text Key: 69301591
• Report Number: 0002249697-2017-00825
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K903636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

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 Catalogue Number: 2017-0054
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention