MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENTRALIZER 12.0; HIP OTHER IMPLANT

Catalog Number 137621000

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

Patient was revised to address an acetabular bone fracture and cup loosening.The stem was also noted to be loose.Loosening occurred at the cement to femoral stem interface.Cement manufacturer is unknown.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Complaint description: patient was revised to address an acetabular bone fracture and cup loosening.The stem was also noted to be loose.Loosening occurred at the cement to femoral stem interface.Cement manufacturer is unknown.Update (b)(6) 2017: medical records have been reviewed.Op-notes from (b)(6) 2016 indicate the patient sustained and femoral neck fracture due to a fall pre-op.It was decided a total hip arthroplasty was the treatment route needed.The patient was implanted successfully.Revision op-notes (b)(6) 2016 indicate the patient was revised due to acetabular periprosthetic fracture.It was noted the patient experienced a great deal of pain starting after the initial surgery, worsening as time passed.Radiographs revealed that the acetabular component had broken into the pelvis and a revision surgery was necessary.During the surgery it was noted that the acetabular component was broken into the pelvis.A large amount of debris and scarring around the implant including loose soft tissue and hematoma were removed and the liner, screws and cup were removed one at a time.Removal was successful.It was noted there did not appear to be any signs of infection.Also, there was a moderate about of central bone loss, approximately 30% of the acetabulum and there was a posterior column acetabular fracture extending from the sciatic notch at approximately the 10 o¿clock position and exiting into the inferior acetabular at the 6 o¿clock position.Therefore, she had pelvic discontinuity with separation of the informer pelvis from the superior pelvis.The fracture site was very mobile.A plate and screws were placed alone the posterior column.Once attention was turned to the proximal femur it was noted that the trochanter was unstable, therefore, a constrained acetabular liner was used.Estimated blood loss was 800ml with 75ml of concentrated blood available for re-infusion.Updated (b)(6) 2017./ | investigation method: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event./ | investigation summary: patient was revised to address an acetabular bone fracture and cup loosening.The stem was also noted to be loose.Loosening occurred at the cement to femoral stem interface.Cement manufacturer is unknown.Doi: (b)(6) 2016 - dor: (b)(6) 2016 (right hip) no device associated with this report was received for examination.A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.  product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CEMENTRALIZER 12.0
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6178242
• MDR Text Key: 62483896
• Report Number: 1818910-2016-33500
• Device Sequence Number: 1
• Product Code: LTO
• Combination Product (y/n): N
• PMA/PMN Number: K871510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 137621000
• Device Lot Number: C74201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 90