MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CUP; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Arthritis (1723); Fall (1848); Bone Fracture(s) (1870)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.Not returned to manufacturer.

Event Description

Surgeon had a trauma patient come in that had taken a fall in a wet parking lot.Surgeon looked over the x-rays and said he would like to put a new cup, head and mdm liner.The case was later that night and into tuesday.The patient had a chunk of her acetabulum fractured.Surgeon put a new tritanium revision cup with screws to hold it.Patient also needed a new head and mdm liner.The surgeon put two different types of screws in the cup.The tritanium revision cup calls for (b)(6) screws to be used.He had implanted (b)(6).

Manufacturer Narrative

An event regarding a disassociation involving an unknown shell was reported.The event was confirmed through medical review.Method & results: device evaluation could not be performed as no items associated with the event were returned or made available for identification or evaluation.Clinician review: the provided medical records were submitted to a clinician for review who indicated that: "the operative report notes, " last night tripped and twisted her leg acetabular component avulsed out of socket "findings posterior wall of the acetabulum attached to one screw only place with any apparent bone ongrowth the report continues, "after closure x-ray cup looked like it was through the medial wall, the screws looked in horrible position into the pelvis remained stable throughout the procedure." an x-ray report on (b)(6) 2015, which is of an ap of the pelvis and ap and lateral of the right hip states, "lateral and slightly superior dislocation of the acetabular component femoral component and the acetabular component remains congruent ".No x-ray images are available for review, and there is no examination of the explanted components from either the first or second revision surgeries, no primary surgery date, operative report or listing of the primary components available.In this obese rheumatoid patient, there is no evidence this difficult reconstruction of a post-traumatic acetabular disassociation was the result of the faulty design, manufacturing or materials of the primary or revision components implanted.There is no radiographic or implant examination to confirm that the second revision , which was predicted at the time of the review of the post-operative x-rays of the first revision, was contributed to by the use of improper screws to fix the 56 tritanium shell implanted at the first revision.The likelihood of the pelvic disassociation, which was not addressed at the first revision and subsequently required the use of the cage reconstruction, was the main factor in the requirement for the second revision.Should additional medical records become available, this report will be updated." device history review could not be performed as the reported device lot code was not provided.Complaint history review: a review of the complaint databases could not be performed as the reported device was no properly identified.Conclusions: it was reported that patient had taken a fall in a wet parking lot and had a chunk of her acetabulum fractured.The event of shell disassociation was confirmed as per provided medical records which were submitted to clinician who indicated that operative report notes acetabular component avulsed out of socket post trip and twist of her leg.There is no evidence this difficult reconstruction of a post-traumatic acetabular disassociation was the result of the faulty design, manufacturing or materials of the primary or revision components implanted.The root cause could not be determined because the devices were not returned for evaluation and insufficient information was provided.If the devices and additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Surgeon had a trauma patient come in that had taken a fall in a wet parking lot.Surgeon looked over the x-rays and said he would like to put a new cup, head and mdm liner.The case was later that night and into tuesday.The patient had a chunk of her acetabulum fractured.Surgeon put a new tritanium revision cup with screws to hold it.Patient also needed a new head and mdm liner.The surgeon put two different types of screws in the cup.The tritanium revision cup calls for 2080-xxxx screws to be used.He had implanted 2080-xxxx and 2030-xxxx.

• Brand Name: UNKNOWN CUP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5246628
• MDR Text Key: 32033638
• Report Number: 0002249697-2015-04000
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 113