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

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.The manufacturer did not receive x-rays, or other source documents for review.An e-mail requesting the following additional information was sent to the appropriate representatives: was the sterile barrier compromised or damaged? did you notice any damage in the secondary (outer) packaging? this paper-like scraps, were found inside the sterile packaging? in the pictures received, only a scratch or dirt-like spot is visible.These paper-like scraps described in the per, were they also shipped to us for investigation? was the surgeon able to complete the surgery with another device? 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 cmp-(b)(4).

Event Description

It was reported that when the packaging of the ball head was opened it was noticed that paper scraps were clinging onto the surface of the implant.No delay, no patient adverse consequences.

Event Description

Please refer to report 0009613350-2019-00684.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend has been identified.Event description: it was reported that upon opening of the biolox packaging a scrap of paper was found on the surface of the biolox head.Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Device analysis: visual examination: the biolox head has been received with packaging for investigation.The paper like foreign material having a triangular shape was found on the surface of the biolox head.Otherwise, the head does not show any defects or signs usage.Based on this visual examination the reported event can be confirmed.Review of product documentation: this device is intended for treatment.N/a: no compatibility check possible as the product has not been implanted.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.At the supplier site ceramtec the biolox heads are manufactured and inspected.100 biolox heads were delivered from ceramtec on 25-sep-2019.The heads were strung on a washing tray and underwent a microbiological upgrade (washing).After the upgrade the biolox heads directly ended up in the clean room.A particle of a few mm in size would have been removed during the microbiological upgrade.In the clean room, the biolox heads are dried, individually packed into inner blisters and sealed (tyvek) according to the internal processes (q.35.065, q.35.017, q.37.061, q.35.164).Consequently, the biolox heads are packed into outer blisters, sealed and labelled again according to internal processes.Review of the packaging dhr did not show any anomalies.Material certificate reviewed.The review did not identify any anomaly.Sterilization certificate reviewed.The review did not identify any anomaly.Particle analysis: the particle has a right-angled triangular shape (4mm hypotenuse and 2mm in height), a white color and is opaque.Based on the particle's characteristics it is possible that the particle derived from a sterile glove, from a sticker base paper or from packaging material.Conclusion: it was reported that upon opening of the biolox packaging a scrap of paper was found on the surface of the biolox head.The triangular shaped, white particle was found during visual examination on the surface of the biolox head.It is possible that the particle derived from a sterile glove, from a sticker base paper of from packaging material.The exact origin could not be found.The investigation results did not identify a non-conformance or a complaint out of box (coob).The manufacturing documentation as well as the sterilization certificate did not show any anomalies.Nevertheless, it is possible that the particle adhered to the biolox head prior to packaging or it was already in the packaging when the head was packed.It may also be possible that the adherence occurred in the or.The complaint history showed that no similar complaints for this reference number (b)(4) and no additional complaint for this lot number 3005260 have been reported.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, based on the available information, we were not able to identify an exact root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9339819
• MDR Text Key: 197328059
• Report Number: 0009613350-2019-00684
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: 00889024430372
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-03
• Device Lot Number: 3005260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other