MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown stem unknown.Unknown shell unknown.Unknown head unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02132, 0001822565-2023-02133, and 0001822565-2023-02135.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient is being revised for unknown reasons six months post implantation.Patient is inquiring about product information of her initial implants.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10: 00771101210 standard offset size 12.5 reduced neck length 12/14 neck taper uncemented femoral stem 65574069.00620205222 shell porous with cluster holes 52 mm 64933052.00625006520 bone screw self-tapping 6.5 mm dia.20 mm length j7373544.00625006530 bone screw self-tapping 6.5 mm dia.30 mm length 65710435.00-8775-036-01 biolox delta hd 12/14 36x-3.5 3069711.
Event or Problem Description
It was reported that the patient had an initial hip arthroplasty.Subsequently, the patient had an additional procedure due to two torn tendons of the right hip six (6) months post implantation.No implants were removed.No complaint of anything wrong with the implants.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Patient had an initial tha with surgical intervention six months post implantation of zimmer biomet products for repair of tendon tear.Tendon tear postop total hip arthroplasty is found in a small amount of cases.Nonoperative modalities are first line of treatment.If this approach is unsuccessful, surgical treatment may be necessary.Tendon tears can take from 3-6 months to heal with symptoms of pain, stiffness, feeling of hip giving away, instability, and/or catching.An mri will be obtained to determine location and severity of tear to help determine the treatment course.Surgical repair of a tendon tear can be done via arthroscopic or open.The tendon is reattached to the trochanter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS
• Common Device Name: PROTHESIS, 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: 17508546
• Report Number: 0001822565-2023-02134
• Device Sequence Number: 12407214
• Product Code: LPH
• UDI-Device Identifier: 00889024123762
• UDI-Public: (01)00889024123762(17)271025(10)65625892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 10/06/2023

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 Model Number: N/A
• Device Catalogue Number: 00630505036
• Device Lot Number: 65625892
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 10/05/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/07/2023; 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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