MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: g7 pps ltd acetabular shl 48c.Catalog#: 010000661; lot#: 6721216.Liner neutral 32 mm i.D.Size c for use with g7 acetabular system only.Catalog#: 30103203; lot#: 64669012.Femoral stem cementless collared high offset 12/14 taper size 4.Catalog#: 574202040; lot#: 3012866.Therapy date: unknown.The manufacturer received other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the left side and had to undergo a wound debridement due to a superficial infection.Patient reported satisfaction and no other complications.
Event or Problem Description
Patient was implanted on the left side and had to undergo a wound debridement due to a superficial infection.Patient reported satisfaction and no other complications.
Additional Manufacturer Narrative
Additional information was received on oct 15, 2020.Additional: b3.Correction: b4, g4, g7, h2, h10.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Based on information provided from surgeon that dermabond caused incision wound edges to become necrotic requiring medical intervention and treatment of antibiotics as preventive measure; and no indication of implant involvement.Therefore this complaint will be set to not-a-complaint as the patient had reaction to another manufacturers product.Therefore this mdr is obsolete.Please invalidate the case from your system.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 32/-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
• MDR Report Key: 10634675
• Report Number: 0009613350-2020-00466
• Device Sequence Number: 11675024
• Product Code: LZO
• UDI-Device Identifier: 00889024430310
• UDI-Public: 00889024430310
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-01
• Device Lot Number: 3013059
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/15/2020; 10/28/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/23/2020; 11/02/2020
• 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
• Patient Age: 68 YR
• Patient Weight: 68