MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX¿¢, HEAD, L, ø 32/+3.5, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient fell on his left hip which resulted in a fracture of the ceramic head.A revision of the head and inlay were performed together with removal of any fragments from the fractured head.No further outcome for the patient has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.The root cause of the reported issue is attributed to the patient falling.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.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.In total 4 images of the fractured sulox head have been received.The sulox head is broken into 4 parts.Metal smearing can be seen on the articulation surface, the taper surface and the fracture surfaces.A line can be seen near the bottom of the head taper, indicating the seating of the stem taper in the head taper.Metal smearing can also be seen on the bottom of the taper, which was probably transferred after the fracture.The laser marking of the ceramtec labelling is distributed over several fracture fragments and therefore cannot be recognized without gaps.In addition, the marking of the visible fragments is partially blurred and covered/altered by metal smears.Based on the visible labelling parts, the ceramtec labelling is assumed to be 10_23950, which matches with a sulox head ref.17.32.07 size 32/+3.5.The raw material certificate of lot 10_23950 from our supplier ceramtec was reviewed without any anomalies noted.Based on the ceramtec lot number, a unique zb lot number cannot be determined because ceramtec lot 10_23950 was split among a total of 5 zb lots.Therefore, the definite zb dhr, which includes cleaning, packaging and sterilization of the sulox head could not be identified.However, based on the customer data it is believed to be from either zb lot 2578947 or 2581882, as one part from each of these two lots was shipped to the customer involved prior to the implant date.The manufacturing records of both lots were reviewed without any anomalies noted.Device is used for treatment.Review of the complaint history found no additional related issues for this item and the potential lots 2578947 or 2581882.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.In total 4 images of the fractured sulox head have been received.The sulox head is broken into 4 parts.Metal smearing can be seen on the articulation surface, the taper surface and the fracture surfaces.A line can be seen near the bottom of the head taper, indicating the seating of the stem taper in the head taper.Metal smearing can also be seen on the bottom of the taper, which was probably transferred after the fracture.The laser marking of the labeling is distributed over several fracture fragments and therefore cannot be recognized without gaps.In addition, the marking of the visible fragments is partially blurred and covered/altered by metal smears.Based on the visible labeling parts, the labeling is assumed to be 10_23950, which matches with a sulox head ref.17.32.07 size 32/+3.5.The raw material certificate of lot: 10_23950 from our supplier was reviewed without any anomalies noted.Based on the supplier lot number, a unique zb lot number cannot be determined because lot: 10_23950 was split among a total of (b)(4) zb lots.Therefore, the definite zb dhr, which includes cleaning, packaging and sterilization of the sulox head could not be identified.However, based on the customer data it is believed to be from either zb lot: 2578947 or 2581882, as one part from each of these two lots was shipped to the customer involved prior to the implant date.The manufacturing records of both lots were reviewed without any anomalies noted.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.

Event Description

No further event information available at the time of this report.

• Brand Name: SULOX¿¢, HEAD, L, ø 32/+3.5, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• 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: 14539617
• MDR Text Key: 292959284
• Report Number: 0009613350-2022-00308
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024416994
• UDI-Public: (01)00889024416994
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 17.32.07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female