MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIV 2-HOLE SHL 54MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Damage (2104); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Foreign report source: (b)(6).
Event or Problem Description
It was reported that during an initial surgery pieces of the metal threads on the cup came loose and fell into the patient's bone cavity.Surgeon had to remove the cup and flush out the debris.Due to the removal of the cup and the additional tapping to re-implant after flushing, there was damage to the bone.Attempts have been made and no further information has been provided.
Event or Problem Description
Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: a1, a4, a5, b4, b5, b7, g4, g7, h1, h2, h10.Corrected: e1, e2, e3.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.G2: report source china.Reported event was unable to be confirmed due to limited information provided by the customer.The dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.A summary of the investigation as requested and sent the customer.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 that during a hip procedure, the cup was implanted successfully.The surgeon¿s glove was punctured by the locking ring and they needed to be replaced.There was no reported issue with the products and remain implanted.Attempts have been made and no additional information is available at this time.

• Brand Name: UNIV 2-HOLE SHL 54MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11013827
• Report Number: 0001825034-2020-04361
• Device Sequence Number: 3618074
• Product Code: LPH
• UDI-Device Identifier: 00880304229891
• UDI-Public: (01)00880304229891
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-103654
• Device Lot Number: 009940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/31/2020; 03/05/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/15/2021; 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Other
• Patient Age: 64 YR
• Patient Weight: 63