MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had undergone an initial left hip arthroplasty due to ankylosing spondylitis and was discharged with a good recovery.After the operation, the patient developed redness and pain in the left hip and underwent debridement treatment.Patient was discharged with a good recovery afterwards.The patient's infection was reported to be superficial; the joint cavity was not opened and the joint prosthesis was not exposed.Hospital reported the event as patient's own cause.Attempts have been made and no further information has been provided.Investigation has been completed.
Additional Manufacturer Narrative
Zimmer biomet reference: (b)(4).Customer has indicated that the product remains implanted.The device will not be returned for analysis.Investigation results are now available.Device history record (dhr) review was unable to be performed as the lot number of the device here reported is unknown.Medical product: 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners; catalog#: 00-8757-054-01; lot#: unknown.Femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 12 128 mm stem length cementless; catalog#: 00-7864-012-00; lot#: unknown.Investigation and conclusion: event description: it was reported that the patient underwent left hip arthroplasty on (b)(6) 2019 due to ankylosing spondylitis and was discharged with a good recovery.Two years post implantation, the patient developed redness and pain in the left hip due to a superficial infection without any obvious cause and therefore underwent debridement treatment and discharged with a good recovery and wound healing.The joint cavity was not opened and the prosthesis was not exposed during debridement.It was mentioned that the hospital believes the superficial infection might be related to the poor physical condition of the patient.Harm: s3 - infection, moderate localized.Hazardous situation: patient¿s anatomy is exposed to agents/substances of unknown origin.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Patient data: (b)(6).Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: the quality records for the biolox liner show that all specified characteristics have met the specifications valid at the time of production.The quality records for the biolox head could not be reviewed due to missing product identification.Sterilization certificate: the sterilization certificate was reviewed for the biolox liner and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.The sterilization certificate for the biolox head could not be reviewed due to missing product identification.Conclusion: it was reported that the patient underwent left hip arthroplasty on (b)(6) 2019 due to ankylosing spondylitis and was discharged with a good recovery.Two years post implantation, the patient developed redness and pain in the left hip due to a superficial infection without any obvious cause and therefore underwent debridement treatment and was discharged with a good recovery and wound healing.The joint cavity was not opened and the prosthesis was not exposed during debridement.It was mentioned that the hospital believes the superficial infection might be related to the poor physical condition of the patient.The quality records for the biolox liner show that all specified characteristics have met the specifications valid at the time of production.The quality records for the concomitant devices could not be reviewed due to missing product identification.Nevertheless, the investigation did not identify a nonconformance or a complaint out of box (coob).Sterilization certification of the biolox liner was reviewed and found to be conforming with no applicable deviations.The device was verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.Moreover, no trend on infection has been observed for this product family.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.The sterilization certification for the concomitant devices could not be reviewed due to missing product identification.No medical documents such as operatives notes, office visit notes or lab reports were received for review.No relevant patient medical history other that it being mentioned that he superficial infection might be related to the poor physical condition of the patient was shared.Based on the investigation the reported event cannot be confirmed.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, the implanted products could not be identified as the source or as a potential contribution to the reported event of infection.Therefore, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.Multiple mdr reports were filed for this event, please see associated report: 0009613350-2022-00210 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.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14042906
• Report Number: 0009613350-2022-00220
• Device Sequence Number: 6298326
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: 00889024430358
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: 00-8775-036-01
• Device Lot Number: UNKNOWN
• 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: 03/08/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male