MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. REVISION SHELL LINER CEMENTED 28 MM I.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref (b)(4) lot 2939042 cage shell/liner.Ref (b)(4) lot j7254214, j7234925 screw x2.Ref (b)(4) lot j7185033, j7263672 screw x2.Ref (b)(4) lot j6717381 screw.Unk demineralized bone matrix and allograft.Unk cement.Medacta 10.5/28 head.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent initial right total hip arthroplasty on unknown date with competitor product.Subsequently, patient was revised with zimmer biomet products.Patient underwent another revision approximately 1 (one) month later due to traumatic dislocation.During the revision it was noted a greater trochanter fragment that was not repaired related to soft tissue tension and distraction of the fragment to the remainder of the femur.The head and acetabular components were replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information on the reported event.

• Brand Name: REVISION SHELL LINER CEMENTED 28 MM I.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15527182
• MDR Text Key: 301011321
• Report Number: 0002648920-2022-00203
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00710504828
• Device Lot Number: 64886014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 71 KG