MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH MULTI HOLES POROUS 58 MM O.D. SIZE LL FOR USE WITH LL LINERS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	07/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00771301200 ¿ m/l taper kinectiv stem ¿ 63346813.00784801400 ¿ m/l taper kinectiv neck ¿ 61956654.Unknown liner ¿ unknown part and lot.00877504002 ¿ biolox head ¿ 2823276.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.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.As reported the patient's surgical wound site/incision had some abnormal or unexpected redness.This deviation signifies an alteration in the wound healing process.The patient had several comorbidities such as elevated bmi, cardiovascular, and liver disease that would have contributed to this event.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01330, 0001822565-2021-01331, 0001822565-2021-01333.
Event or Problem Description
It was reported that patient presented to physician approximately 2 weeks post initial right hip procedure with lateral redness in a well-approximated, almost healed incision.The patient was placed on oral antibiotics and instructed to return in one week for a follow up.Upon return, it was noted that the incision was completely healed.No further complications were reported concerning the incision.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: SHELL WITH MULTI HOLES POROUS 58 MM O.D. SIZE LL FOR USE WITH LL LINERS
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11819984
• Report Number: 0001822565-2021-01332
• Device Sequence Number: 3223702
• Product Code: LPH
• UDI-Device Identifier: 00889024151475
• UDI-Public: (01)00889024151475(17)260228(10)63290513
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 00875705802
• Device Lot Number: 63290513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/13/2021
• 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 Weight: 83