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

Model Number	N/A
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: allofit it alloclassic, shell for acetabulum, uncemented, 52/ii; catalog#: 00-8755-052-02; lot#: 2737388.Avenir muller, stem, standard, uncemented, ha, 4, taper 12/14; catalog#: 01.06010.004; lot#: 4020629.Liner neutral 36 mm i.D.Size ii for use with 52 mm o.D.Size ii shell; catalog#: 00-8751-010-36; lot#: 62519395.Allofit it alloclassic, shell for acetabulum, uncemented, 50/hh; catalog#: 00-8755-050-00; lot#: 2756567.Therapy date: unknown.The manufacturer did not receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.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 right side and 7 years post implantation started experiencing pain, severe limp and difficulty with adls.No intervention has been reported yet.A leg discrepancy of 0.8 cm has been reported.
Event or Problem Description
Note: in one of the follow-up responses in the complaint, it was stated that the left hip caused the pain and limping, not the right hip (which is where zb devices are implanted).Because of this, it is now clear that the complained products are not zimmer biomet products.Therefore, please delete this report from your system: (b)(4) / mfr: 0009613350-2021-00404-1.
Additional Manufacturer Narrative
Note: in one of the follow-up responses in the complaint, it was stated that the left hip caused the pain and limping, not the right hip (which is where zb devices are implanted).Because of this, it is now clear that the complained products are not zimmer biomet products.Therefore, please delete this report from your system: (b)(4) / mfr: 0009613350-2021-00404-1.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 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 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: 12317962
• Report Number: 0009613350-2021-00404
• Device Sequence Number: 14528513
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: 00889024430372
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-03
• Device Lot Number: 2735781
• 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: 08/01/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Weight: 112 KG