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

Catalog Number	00625006520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530); Periprosthetic fracture (4902)
Date of Event	09/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 32mm size gg elevated rim liner use with 48mm o.D.Size gg shell.Item: 00875200832.Lot: 63225292.Bone screw self-tapping 6.5 mm dia.40 mm length.Item: 00625006540.Lot: 63289719.Bone screw self-tapping 6.5 mm dia.20 mm length.Item: 00625006520.Lot: 63296125.Bone screw self-tapping 6.5 mm dia.25 mm length.Item: 00625006525.Lot: 63196736.48mm o.D.Size gg porous uncemented with multi-holes shell use with gg liners.Item: 00875704802.Lot: 62990313.Cer bioloxd option hd 32mm.Item: 650-1056.Lot: 007000.G2: foreign ¿ canada.The customer indicated that the product location is unknown; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a left hip revision approximately 1-month post implantation due to dislocation.During the revision, noted periprosthetic fracture of the pelvis posteriorly to the acetabulum including the acetabular roof.An old pseudotumor was excised.The fracture is repaired using a plate, screws, bone cement along with a shell, head, and taper adapter without complications.It was confirmed that no further information could be provided.
Event or Problem Description
It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no related 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 in (b)(6) 2010.A revision occurred in (b)(6)2016 due to metal related pathology and difficulties with adls.A second revision occurred in (b)(6) 20216 due to dislocation.The acetabulum was also noted to be fractured, with numerous fragments in the posterior wall.The old pseudotumor was also excised.The bone fracture was repaired, with a new shell, screws, and liner placed.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 trends.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM
• 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 BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23879064
• Report Number: 0002648920-2025-00370
• Device Sequence Number: 15865722
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 00625006520
• Device Lot Number: 63272712N
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2016
• 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 H11; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female