MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY BONE SCR 6.5X30; PROSTHESIS, HIP

Catalog Number	00625006530
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Malaise (2359); Swelling/ Edema (4577); Atrophy (4913)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient started experiencing allergy symptoms around the implant sight.Patient alleges breaking out in hives.After consulting with a dermatologist, it was discovered a screw was protruding into the muscle.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} d10: cat# 00786401400 lot# 63559502 femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 14 149 mm stem length cementless cat# 00875101136 lot# 64389282 36mm i.D.Size jj neutral liner use with 54mm o.D.Size jj shell cat# 00875705401 lot# 64310968 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners cat# 00801803602 lot# 64291597 femoral head 0x36mm dia.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: a4; b5; b7; g3; h2; h6.
Event or Problem Description
It was reported the patient underwent an initial right total hip arthroplasty.The patient reports ongoing intermittent pain since surgery.Subsequently, the patient also developed a dermatological hive-like breakout approximately 5 years post-implantation which has persisted periodically since.Of note, it was demonstrated on mri that the acetabular screw does protrude into the muscle although no revision of the product placement or intervention is planned at this time.Current evaluation by allergy and rheumatology is ongoing and the outcome is pending.Further details have not been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d5; g3; h2; h3; h6.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.Patient's medical history was provided and reviewed by a health care professional.Review of the available records identified the following: patient had an initial right tha.Patient reported ongoing intermittent pain since surgery, the skin broke out in a large area on right thigh up to top of right buttock.Also experiencing painful burning and itching.Patient reported having flu-like symptoms a few days prior to breakout.An mri report was also provided and shows acetabular cup screw projects beyond the medial wall of the acetabulum and into the right iliopsoas muscle.Mild edema deep to the right psoas muscle.A definitive root cause cannot be determined.Based on the medical timeline, the complaint is confirmed.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
No further information at the time of this report.

• Brand Name: TRILOGY BONE SCR 6.5X30
• 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: 22003434
• Report Number: 0002648920-2025-00132
• Device Sequence Number: 7313750
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)280930(10)64172342
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/27/2025

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: 00625006530
• Device Lot Number: 64172342
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 05/16/2025; 08/05/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 05/16/2025; 05/29/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 119 KG