MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-232
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Primary procedure, left hip.It was reported that a femoral head was labelled as a 32 +4 biolox head, but inside the packaging was a 32 -4 biolox head.Discovery was made when the head was impacted on the stem and the surgeon noted the head was sitting lower than expected.As there were no other biolox heads at the hospital a 32 +4 lfit head was implanted instead.Surgery was completed successfully with a delay of approximately 2-3 minutes.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been 3 other events for the lot referenced.The following devices were also listed in this report: delta v-40 ceramic head 32/-4; cat# 6570-0-032; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
Primary procedure, left hip.It was reported that a femoral head was labelled as a 32 +4 biolox head, but inside the packaging was a 32 -4 biolox head.Discovery was made when the head was impacted on the stem and the surgeon noted the head was sitting lower than expected.As there were no other biolox heads at the hospital a 32 +4 lfit head was implanted instead.Surgery was completed successfully with a delay of approximately 2-3 minutes.
Additional Manufacturer Narrative
Reported event: an event regarding product mix involving a ceramic head was reported.The event was confirmed by review of the photographs provided.Method & results: product evaluation and results: the outer box of the device shows catalog number 6570-0-232, lot 89546202 on the label and also shows that the device was intended to be a 32mm head with a nk lnth of +4mm.A photo showing that the device packaged bears the marking 32mm -4.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 8 other similar events for the lot referenced.Conclusions: the reported product mix was confirmed.Nc was raised to further address this event.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13289963
• Report Number: 0002249697-2022-00102
• Device Sequence Number: 11911933
• Product Code: JDI
• UDI-Device Identifier: 04546540608536
• UDI-Public: 04546540608536
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6570-0-232
• Device Catalogue Number: 6570-0-232
• Device Lot Number: 89546202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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: PFA 2902313
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female