MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 46 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products: catalog number:00875100728, lot number:64165957, brand name: acetabular liner.Catalog number:163660, lot number: j6303568, brand name: cocr head.Catalog number: 21-103202, lot number: 6252580, brand name: taperloc femoral stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01928.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.Device remains implanted in the patient.
Event or Problem Description
It was reported that a patient had an initial hip surgery.Approximately 2 weeks post implantation, the patient began experiencing drainage from the wound.An irrigation and debridement procedure was performed.A few days later, the patient dislocated the hip and was revised.The assumption of a deep infection was reported.The liner was revised, which was visibly delaminating.Attempts have been made, and no further information has been provided.
Event or Problem Description
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.
Additional Manufacturer Narrative
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: SHELL WITH CLUSTER HOLES POROUS 46 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10106742
• Report Number: 0001822565-2020-01929
• Device Sequence Number: 11587626
• Product Code: LPH
• UDI-Device Identifier: 00889024150119
• UDI-Public: (01)00889024150119(17)300429(10)64326501
• Combination Product (Y/N): N
• Initial Reporter Country: ET
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875304601
• Device Lot Number: 64326501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/17/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 39 YR
• Patient Weight: 60