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

Catalog Number	00625006520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow-up visit two weeks post-implantation, the patient presented with slow would healing and was prescribed an antibiotic.At the next follow-up, the issue was resolved, and all components remain implanted without complication.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: g7 vit e neutral lnr 36mm d, item: 30103604, lot: 67403050, z1 std col cmtless sz 1, item: 611201010, lot: zb2500929, g7 osseoti 3 hole shell 50mm d, item: 110010243, lot: 67363267, biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14, item: 00877503602, lot: 3239381.The customer indicated that the product remains implanted; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b7; e1; g3; h2.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
No additional information available for the reported event.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h4; h6; h10 review of the reported event by a health care professional found: - it is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.- a surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.- the expression "wound concerns" or "non-healing wound" would imply that the appearance of the wound deviates from what a surgical wound should appear.- it may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.- this deviation signifies an alteration in the wound healing process which can be complicated by patient comorbidities such as diabetes, obesity, smoking, and other conditions that are known to slow a person's ability to heal.- wound complications can be treated conservatively or invasively depending on the severity of the wound infection and patient status.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.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. 20MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24582487
• Report Number: 0001822565-2026-00790
• Device Sequence Number: 21140519
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2026

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 Catalogue Number: 00625006520
• Device Lot Number: J7959844
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 06/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/08/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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
• Patient Sex: Female
• Patient Weight: 245 LB