MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 20 MM LENGTH 6.5 MM DIA.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-1057, lot# 2958832, cer bioloxd option hd 36mm.Cat# 650-1065, lot# 2959085, cer option type 1 tpr sleve -3.Cat# 010000856, lot# 6443904, g7 neutral e1 liner 36mm d.Cat# 010000662, lot# 6549335, g7 pps ltd acet shell 50d.Cat# 00-6624-065-25, lot# 64732037, bone screw self-tapping 25 mm length 6.5 mm dia.Cat# 00-6624-065-30, lot# 64088045, bone scr 6.5x30 self-tap.Cat# 00-6624-065-30, lot# 64834709, bone scr 6.5x30 self-tap.Cat# 00-6624-065-40, lot# 65479684, bone screw self-tapping 40 mm length 6.5 mm dia.Cat# 00-6624-065-20, lot# 64202817, bone screw self-tapping 20 mm length 6.5 mm dia.Cat# 00-6624-065-20, lot# 64202817, bone screw self-tapping 20 mm length 6.5 mm dia.Cat# 00-6624-065-25, lot# 63436750, bone screw self-tapping 25 mm length 6.5 mm dia.Cat# 00-6624-065-25, lot# 64834697, bone screw self-tapping 25 mm length 6.5 mm dia.It was reported that 1 of the 9 screws fractured during the revision surgery.It is unknown at this time which screw fractured.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.A revision occurred approximately 4 years later due to pain, noise, instability, and osteolysis.While placing the cage during the revision, one of the screws broke and remained implanted.No complications were noted.A definitive root cause cannot be determined.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 initial left total hip arthroplasty that was subsequently revised approximately 4 years later due to pain, noise, instability, osteolysis, and loosening.During the revision while placing the cage noted a screw broke, was unable to retrieve broken part, and remained implanted.Another screw was utilized without complications.Attempts have been made and no further information is available.

• Brand Name: BONE SCREW SELF-TAPPING 20 MM LENGTH 6.5 MM DIA.
• 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: 17405494
• Report Number: 0002648920-2023-00170
• Device Sequence Number: 20706303
• Product Code: LPH
• UDI-Device Identifier: 00889024127647
• UDI-Public: (01)00889024127647(17)310102(10)64825910
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K921308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00662406520
• Device Lot Number: 64825910
• 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: 07/25/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Male
• Patient Weight: 81 KG