MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 47 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref 00500104728 lot 65299113 bipolar liner 47/48/49mm od x 28 id.Ref 802202803 lot 65396117 ab 12/14 cocr head 28mm x +3.5.Ref 007850-013-20 lot 65366732 versys advocate cemented stem 13x130 extended.Ref 00785901000 lot 65493358 versys distal centralizer 10mm unknown cement.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was converted to a total hip arthroplasty due to recurrent dislocations.During the revision a large hematoma was encountered, as well as tissue damage.The femoral stem was found to be well fixed and zimmer products were placed upon completion.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined for the dislocations.No problem was found with the device in relation to the hematoma, as review by a health care professional determined it was procedure related.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 or Problem Description
It was reported a patient had a left bipolar hemiarthroplasty after a mechanical fall causing a displaced basicervical fracture of the femoral neck.Subsequently, patient underwent a conversion to a total hip arthroplasty due to recurrent dislocations approximately 1 (one) month later.During the revision a large hematoma was evacuated around the anterior, posterior, and superior hip.Damage was found to the gluteus medius and anterior capsule.The stem was found well fixed.The cup, liner and head were replaced.No further event information available at the time of this report.

• Brand Name: SHELL 47 MM O.D.
• Common Device Name: 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: 15513529
• Report Number: 0002648920-2022-00204
• Device Sequence Number: 5242419
• Product Code: KWL
• UDI-Device Identifier: 00889024115354
• UDI-Public: (01)00889024115354(17)320209(10)65299082
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00500104700
• Device Lot Number: 65299082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 71 KG